Trial Outcomes & Findings for Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations (NCT NCT01752920)

NCT ID: NCT01752920

Last Updated: 2023-06-05

Results Overview

Adverse events were graded for severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. CTCAE is classifying AEs and their associated severity from Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe or medically significant but not immediately life-threatening), Grade 4 (Life-threatening consequences) to Grade 5 (Death related to AE)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 119 participants
• Primary outcome timeframe: Adverse events were collected and reported from the time of receiving first dose of derazantinib to the end of study assessment and follow-up period (30-day post-treatment)
• Results posted on: 2023-06-05

Participant Flow

The study was conducted in 12 study centers, 8 in the US and 4 in Italy. 119 subjects were recruited between December 2012 and January 2017.

A fresh core needle biopsy or fine needle aspiration could be collected during the screening period if archival tumor tissue biopsy samples were not available.

Participant milestones

Measure	Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group Subjects who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group Subjects who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 400 mg QOD - 425 mg QD - High Dose Group Subjects who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 300 mg QD - Expanded Cohort Group Subjects who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
Overall Study STARTED	29	13	19	58
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	29	13	19	58

Reasons for withdrawal

Measure	Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group Subjects who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group Subjects who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 400 mg QOD - 425 mg QD - High Dose Group Subjects who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 300 mg QD - Expanded Cohort Group Subjects who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
Overall Study Adverse Event	1	0	5	10
Overall Study Clinical Disease Progression	6	4	1	13
Overall Study Physician Decision	1	0	0	3
Overall Study Radiographic Disease Progression	20	7	12	29
Overall Study Study Terminated by Sponsor	0	0	0	1
Overall Study Withdrawal by Subject	0	1	0	1
Overall Study Lack of clinical benefit	1	1	1	1

Baseline Characteristics

Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations

Baseline characteristics by cohort

Measure	Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group n=29 Participants Patients who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 250 mg QOD - 325 mg QD - Middle Dose Group n=13 Participants Patients who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 400 mg QOD - 425 mg QD - High Dose Group n=19 Participants Patients who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 300 mg QD - Expanded Cohort Group n=58 Participants Patients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Total n=119 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	35 Participants n=4 Participants	66 Participants n=21 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	23 Participants n=4 Participants	53 Participants n=21 Participants
Age, Continuous	60 years n=5 Participants	67 years n=7 Participants	66 years n=5 Participants	60.5 years n=4 Participants	63 years n=21 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	32 Participants n=4 Participants	69 Participants n=21 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants	50 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants	56 Participants n=4 Participants	110 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants	54 Participants n=4 Participants	105 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants

PRIMARY outcome

Timeframe: Adverse events were collected and reported from the time of receiving first dose of derazantinib to the end of study assessment and follow-up period (30-day post-treatment)

Population: The safety population included all subjects who received at least one dose of derazantinib.

Adverse events were graded for severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. CTCAE is classifying AEs and their associated severity from Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe or medically significant but not immediately life-threatening), Grade 4 (Life-threatening consequences) to Grade 5 (Death related to AE)

Outcome measures

Measure	Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group n=29 Participants Patients who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 250 mg QOD - 325 mg QD - Middle Dose Group n=13 Participants Patients who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 400 mg QOD - 425 mg QD - High Dose Group n=19 Participants Patients who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 300 mg QD - Expanded Cohort Group n=58 Participants Patients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) no TEAE	1 Participants	0 Participants	0 Participants	0 Participants
Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) TEAE Grade 1	3 Participants	1 Participants	1 Participants	11 Participants
Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) TEAE Grade 2	14 Participants	5 Participants	3 Participants	14 Participants
Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) TEAE Grade 3	9 Participants	6 Participants	13 Participants	24 Participants
Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) TEAE Grade 4	0 Participants	1 Participants	0 Participants	4 Participants
Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) TEAE Grade 5	2 Participants	0 Participants	2 Participants	5 Participants

SECONDARY outcome

Timeframe: Assessments were performed at Baseline, and every 8 weeks during continuous drug administration until the End of Treatment visit (7 [+3] days after the last dose of derazantinib) or as otherwise clinically indicated.

Population: Evaluable Population: patients who received at least one cycle of study treatment and had at least one postbaseline tumor evaluation.

The number of patients with an objective tumor response, which included those with either a complete response (CR) or a partial response (PR) based on RECIST v1.1 guidelines which defines criteria for the radiological assessment in tumor response.

The objective response rate (ORR) was defined as the proportion of patients with a CR or PR.

Outcome measures

Measure	Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group n=29 Participants Patients who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 250 mg QOD - 325 mg QD - Middle Dose Group n=13 Participants Patients who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 400 mg QOD - 425 mg QD - High Dose Group n=19 Participants Patients who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 300 mg QD - Expanded Cohort Group n=58 Participants Patients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
Proportion of Patients With an Objective Tumor Response Per RECIST 1.1	0 Participants	0 Participants	1 Participants	5 Participants

SECONDARY outcome

Timeframe: Assessments were performed at Baseline, and every 8 weeks during continuous drug administration until the End of Treatment visit (7 [+3] days after the last dose of derazantinib) or as otherwise clinically indicated.

The number of patients with tumor disease control, which included those with either a complete or partial tumor response, or a stable disease (SD) based on RECIST v1.1 guidelines which defines criteria for the radiological assessment in tumor response. The disease control rate (DCR) was defined as the proportion of patients with CR, PR or SD.

Outcome measures

Measure	Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group n=29 Participants Patients who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 250 mg QOD - 325 mg QD - Middle Dose Group n=13 Participants Patients who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 400 mg QOD - 425 mg QD - High Dose Group n=19 Participants Patients who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 300 mg QD - Expanded Cohort Group n=58 Participants Patients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
Proportion of Patients With Disease Control Per RECIST 1.1	8 Participants	4 Participants	7 Participants	32 Participants

SECONDARY outcome

Timeframe: Assessments were performed at Baseline, and every 8 weeks during continuous drug administration until the End of Treatment visit (7 [+3] days after the last dose of derazantinib) or as otherwise clinically indicated.

PFS was calculated as the time from the date of first dose until documented radiographic disease progression or death from any cause, whichever occurred first. Disease progression is measured according to a specified radiologic increase in tumor size.

Outcome measures

Measure	Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group n=29 Participants Patients who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 250 mg QOD - 325 mg QD - Middle Dose Group n=13 Participants Patients who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 400 mg QOD - 425 mg QD - High Dose Group n=19 Participants Patients who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 300 mg QD - Expanded Cohort Group n=58 Participants Patients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
Progression-free Survival (PFS)	8.3 weeks Interval 6.3 to 9.3	15.3 weeks Interval 6.7 to 22.1	8.1 weeks Interval 6.7 to 23.9	17.4 weeks Interval 7.9 to 24.9

Adverse Events

Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group

Serious events: 9 serious events

Other events: 28 other events

Deaths: 2 deaths

Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Derazantinib 400 mg QOD - 425 mg QD - High Dose Group

Serious events: 6 serious events

Other events: 19 other events

Deaths: 2 deaths

Derazantinib 300 mg QD - Expanded Cohort Group

Serious events: 16 serious events

Other events: 58 other events

Deaths: 5 deaths

Serious adverse events

Measure	Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group n=29 participants at risk Patients who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group n=13 participants at risk Patients who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 400 mg QOD - 425 mg QD - High Dose Group n=19 participants at risk Patients who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 300 mg QD - Expanded Cohort Group n=58 participants at risk Patients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
Investigations Electrocardiogram QT prolonged	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Electrocardiogram abnormal	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Cardiac disorders Cardiomyopathy	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Dizziness	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Encephalopathy	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Spinal cord injury cervical	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Syncope	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	10.5% 2/19 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Pneumothorax	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Enterocutaneous fistula	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Nausea	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Odynophagia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Small intestinal obstruction	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Stomatitis	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Vomiting	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Dehydration	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Abdominal wall abscess	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Appendicitis	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Pneumonia	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.2% 3/58 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Pyelonephritis	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Sepsis	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Urinary tract infection	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Vascular disorders Hypertension	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Chest pain	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Disease progression	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.2% 3/58 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders General physical health deterioration	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.2% 3/58 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Pyrexia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Hepatobiliary disorders Cholangitis	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Hepatobiliary disorders Cholangitis acute	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Other adverse events

Measure	Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group n=29 participants at risk Patients who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group n=13 participants at risk Patients who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 400 mg QOD - 425 mg QD - High Dose Group n=19 participants at risk Patients who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.	Derazantinib 300 mg QD - Expanded Cohort Group n=58 participants at risk Patients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
Renal and urinary disorders Proteinuria	10.3% 3/29 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Oesophageal candidiasis	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Pyrexia	10.3% 3/29 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	10.3% 6/58 • Number of events 9 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Alanine aminotransferase increased	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	23.1% 3/13 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	21.1% 4/19 • Number of events 6 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	29.3% 17/58 • Number of events 31 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Aspartate aminotransferase increased	24.1% 7/29 • Number of events 10 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	53.8% 7/13 • Number of events 10 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	52.6% 10/19 • Number of events 14 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	29.3% 17/58 • Number of events 30 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Bilirubin conjugated increased	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Blood alkaline phosphatase increased	27.6% 8/29 • Number of events 8 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.4% 2/13 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Blood creatine phosphokinase increased	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Blood creatinine increased	13.8% 4/29 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	21.1% 4/19 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	6.9% 4/58 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Blood lactate dehydrogenase increased	17.2% 5/29 • Number of events 6 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.4% 2/13 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.8% 3/19 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Blood thyroid stimulating hormone increased	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Blood urea increased	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.8% 3/19 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Breath sounds abnormal	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	10.5% 2/19 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Electrocardiogram QT interval abnormal	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Electrocardiogram QT prolonged	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Visual acuity tests abnormal	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Weight decreased	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	10.5% 2/19 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Cardiac disorders Cardiomegaly	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Cardiac disorders Pericardial effusion	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Cardiac disorders Tachycardia	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Congenital, familial and genetic disorders Ichthyosis	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Blood and lymphatic system disorders Anaemia	24.1% 7/29 • Number of events 12 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	23.1% 3/13 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	17.2% 10/58 • Number of events 18 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Blood and lymphatic system disorders Leukopenia	3.4% 1/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.8% 3/19 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.2% 3/58 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Ataxia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Balance disorder	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Burning sensation	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Clumsiness	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Dizziness	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	26.3% 5/19 • Number of events 11 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.5% 9/58 • Number of events 15 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Dizziness postural	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.4% 2/13 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Dysgeusia	10.3% 3/29 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	23.1% 3/13 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.8% 3/19 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	19.0% 11/58 • Number of events 14 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Head discomfort	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Headache	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.8% 3/19 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	20.7% 12/58 • Number of events 14 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Hypoaesthesia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Memory impairment	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	10.5% 2/19 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Neuropathy peripheral	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	6.9% 4/58 • Number of events 7 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Paraesthesia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Somnolence	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	8.6% 5/58 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Tremor	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	6.9% 4/58 • Number of events 6 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Eye disorders Conjunctivitis	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	8.6% 5/58 • Number of events 9 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Eye disorders Dry eye	3.4% 1/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.4% 2/13 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	12.1% 7/58 • Number of events 8 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Eye disorders Lacrimation increased	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Eye disorders Vision blurred	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	12.1% 7/58 • Number of events 14 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Eye disorders Visual acuity reduced	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	8.6% 5/58 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Eye disorders Visual impairment	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Ear and labyrinth disorders Ear pain	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Ear and labyrinth disorders Hearing impaired	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Ear and labyrinth disorders Tinnitus	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Cough	13.8% 4/29 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	12.1% 7/58 • Number of events 7 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Dysphonia	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.7% 6/29 • Number of events 6 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	8.6% 5/58 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	13.8% 8/58 • Number of events 9 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	6.9% 4/58 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Nasal mucosal disorder	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.2% 3/58 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Wheezing	3.4% 1/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	10.5% 2/19 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Abdominal distension	10.3% 3/29 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	10.3% 6/58 • Number of events 6 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Abdominal pain	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.4% 2/13 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	8.6% 5/58 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Abdominal pain upper	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	23.1% 3/13 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Ascites	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	6.9% 4/58 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Cheilitis	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Constipation	17.2% 5/29 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	30.8% 4/13 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	36.8% 7/19 • Number of events 9 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	27.6% 16/58 • Number of events 20 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Diarrhoea	20.7% 6/29 • Number of events 11 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	38.5% 5/13 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	47.4% 9/19 • Number of events 10 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	29.3% 17/58 • Number of events 37 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Dry mouth	10.3% 3/29 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	31.6% 6/19 • Number of events 8 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	32.8% 19/58 • Number of events 23 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Dyspepsia	10.3% 3/29 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.8% 3/19 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	10.3% 6/58 • Number of events 7 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Flatulence	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.2% 3/58 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.4% 2/13 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.8% 3/19 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Hiatus hernia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Lip disorder	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Lip dry	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Lip pain	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Nausea	48.3% 14/29 • Number of events 18 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	61.5% 8/13 • Number of events 14 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	68.4% 13/19 • Number of events 15 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	46.6% 27/58 • Number of events 46 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Odynophagia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Oesophagitis	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Stomatitis	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	6.9% 4/58 • Number of events 6 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Tongue disorder	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Vomiting	34.5% 10/29 • Number of events 11 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.4% 2/13 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	36.8% 7/19 • Number of events 7 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	39.7% 23/58 • Number of events 48 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Dysuria	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Hydronephrosis	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Micturition frequency decreased	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Pollakiuria	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Renal and urinary disorders Urinary incontinence	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Acne	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Alopecia	3.4% 1/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	19.0% 11/58 • Number of events 11 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Decubitus ulcer	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Dry skin	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.4% 2/13 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	26.3% 5/19 • Number of events 6 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	8.6% 5/58 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Erythema	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Night sweats	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Onychomadesis	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Pruritus	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.2% 3/58 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Rash	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	6.9% 4/58 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Rash maculo-papular	10.3% 3/29 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Scab	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Scar	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	10.5% 2/19 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Back pain	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	10.5% 2/19 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	6.9% 4/58 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Pain in extremity	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Endocrine disorders Hypothyroidism	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Cachexia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Decreased appetite	41.4% 12/29 • Number of events 14 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	23.1% 3/13 • Number of events 6 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	31.6% 6/19 • Number of events 8 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	22.4% 13/58 • Number of events 15 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Dehydration	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	21.1% 4/19 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.2% 3/58 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.8% 3/19 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hyperkalaemia	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.2% 3/58 • Number of events 6 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hypoalbuminaemia	20.7% 6/29 • Number of events 10 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	23.1% 3/13 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hypokalaemia	10.3% 3/29 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	23.1% 3/13 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	10.5% 2/19 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hypomagnesaemia	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hyponatraemia	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.8% 3/19 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	8.6% 5/58 • Number of events 6 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hypophosphataemia	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Candidiasis	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Cystitis	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Ear infection	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Oral herpes	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Pharyngitis	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Pneumonia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Skin infection	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Upper respiratory tract infection	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	10.5% 2/19 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Urinary tract infection	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	10.5% 2/19 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Contusion	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Excoriation	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Fall	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	15.8% 3/19 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Head injury	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Joint injury	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injury, poisoning and procedural complications Scratch	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	10.3% 3/29 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Vascular disorders Flushing	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Vascular disorders Haematoma	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Vascular disorders Hypertension	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	21.1% 4/19 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	8.6% 5/58 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Vascular disorders Hypotension	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Asthenia	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	22.4% 13/58 • Number of events 26 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Chest pain	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	6.9% 4/58 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Discomfort	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Fatigue	62.1% 18/29 • Number of events 24 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	61.5% 8/13 • Number of events 14 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	57.9% 11/19 • Number of events 18 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	44.8% 26/58 • Number of events 40 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Feeling abnormal	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Feeling hot	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Gait disturbance	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	10.5% 2/19 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Malaise	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Mucosal inflammation	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.2% 3/58 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Non-cardiac chest pain	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Oedema	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Oedema peripheral	3.4% 1/29 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	6.9% 4/58 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Pain	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	1.7% 1/58 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Performance status decreased	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/19 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Psychiatric disorders Anxiety	13.8% 4/29 • Number of events 5 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	23.1% 3/13 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	10.5% 2/19 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	3.4% 2/58 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Psychiatric disorders Depression	10.3% 3/29 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.2% 3/58 • Number of events 3 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Psychiatric disorders Hallucination	0.00% 0/29 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/13 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	5.3% 1/19 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	0.00% 0/58 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Psychiatric disorders Insomnia	6.9% 2/29 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	7.7% 1/13 • Number of events 1 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	10.5% 2/19 • Number of events 2 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	6.9% 4/58 • Number of events 4 • Adverse events were recorded from the first administration of study drug up to 30 days after the last study drug administration. The average period of time for AE data collection was 28 weeks. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Additional Information

Study Director

Basilea Pharmaceutica International Ltd.

Phone: +41 79 701 0551

Email: marc.engelhardt@basilea.com

Results disclosure agreements

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

Restriction type: GT60