Trial Outcomes & Findings for Phase 2 Study of Durvalumab (MEDI4736) in Patients With Glioblastoma (NCT NCT02336165)

NCT ID: NCT02336165

Last Updated: 2022-10-12

Results Overview

OS-12 with 90% confidence interval (CI) is the primary endpoint of Cohort A and is the percentage of subjects who remain alive at 12 months, where OS is measured from the time of diagnosis until the recorded date of death or last follow-up. Subjects who are lost to follow-up at the time of the analysis will be censored on the date of last follow-up.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 159 participants
• Primary outcome timeframe: Up to 12 months
• Results posted on: 2022-10-12

Participant Flow

Participant milestones

Measure	Cohort A Subjects with newly diagnosed unmethlyated O\^6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) glioblastoma (GBM) receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.	Cohort B Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) as monotherapy.	Cohort B2 Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort C Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.
Overall Study STARTED	40	31	33	33	22
Overall Study COMPLETED	6	6	2	2	0
Overall Study NOT COMPLETED	34	25	31	31	22

Reasons for withdrawal

Measure	Cohort A Subjects with newly diagnosed unmethlyated O\^6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) glioblastoma (GBM) receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.	Cohort B Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) as monotherapy.	Cohort B2 Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort C Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.
Overall Study Death	3	0	0	0	1
Overall Study Physician Decision	2	2	1	1	0
Overall Study Withdrawal by Subject	0	0	1	0	1
Overall Study Adverse Event	4	1	2	4	1
Overall Study Progressive disease	23	22	27	24	19
Overall Study Non-compliance	1	0	0	1	0
Overall Study Other	1	0	0	1	0

Baseline Characteristics

Phase 2 Study of Durvalumab (MEDI4736) in Patients With Glioblastoma

Baseline characteristics by cohort

Measure	Cohort A n=40 Participants Subjects with newly diagnosed unmethlyated MGMT GBM receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.	Cohort B n=31 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) as monotherapy.	Cohort B2 n=33 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 n=33 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort C n=22 Participants Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Total n=159 Participants Total of all reporting groups
Age, Continuous	57.0 years n=5 Participants	54.0 years n=7 Participants	57.0 years n=5 Participants	54.0 years n=4 Participants	56.5 years n=21 Participants	56.0 years n=10 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants	13 Participants n=4 Participants	8 Participants n=21 Participants	53 Participants n=10 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	26 Participants n=7 Participants	18 Participants n=5 Participants	20 Participants n=4 Participants	14 Participants n=21 Participants	106 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	27 Participants n=7 Participants	28 Participants n=5 Participants	30 Participants n=4 Participants	19 Participants n=21 Participants	142 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	13 Participants n=10 Participants
Region of Enrollment United States	38 participants n=5 Participants	30 participants n=7 Participants	33 participants n=5 Participants	33 participants n=4 Participants	21 participants n=21 Participants	155 participants n=10 Participants
Region of Enrollment Australia	2 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	4 participants n=10 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ECOG PS 0	24 Participants n=5 Participants	16 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	6 Participants n=21 Participants	65 Participants n=10 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ECOG PS 1	16 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants	23 Participants n=4 Participants	16 Participants n=21 Participants	94 Participants n=10 Participants
O^6-Methylguanine Deoxyribonucleic Acid Methyltransferase (MGMT) Methylation Status Methylated	0 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	9 Participants n=21 Participants	42 Participants n=10 Participants
O^6-Methylguanine Deoxyribonucleic Acid Methyltransferase (MGMT) Methylation Status Unmethylated	40 Participants n=5 Participants	15 Participants n=7 Participants	18 Participants n=5 Participants	18 Participants n=4 Participants	11 Participants n=21 Participants	102 Participants n=10 Participants
O^6-Methylguanine Deoxyribonucleic Acid Methyltransferase (MGMT) Methylation Status Unknown	0 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	15 Participants n=10 Participants
Isocitrate dehydrogenase (IDH) Mutation Status IDH Mutant	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	16 Participants n=10 Participants
Isocitrate dehydrogenase (IDH) Mutation Status Wild Type	35 Participants n=5 Participants	22 Participants n=7 Participants	28 Participants n=5 Participants	30 Participants n=4 Participants	19 Participants n=21 Participants	134 Participants n=10 Participants
Isocitrate dehydrogenase (IDH) Mutation Status Unknown	0 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	9 Participants n=10 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: The population comprises all subjects who received any dose of durvalumab.

OS-12 with 90% confidence interval (CI) is the primary endpoint of Cohort A and is the percentage of subjects who remain alive at 12 months, where OS is measured from the time of diagnosis until the recorded date of death or last follow-up. Subjects who are lost to follow-up at the time of the analysis will be censored on the date of last follow-up.

Outcome measures

Measure	Cohort A n=40 Participants Subjects with newly diagnosed unmethlyated MGMT GBM receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.	Cohort B2 Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort C Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.
Overall Survival Rate at 12 Months (OS-12) as Estimated Using the Kaplan-Meier Method (Cohort A)	60.0 percent of subjects alive Interval 46.1 to 71.4	—	—	—	—

PRIMARY outcome

Timeframe: Up to 6 months

Population: The population comprises all subjects who received any dose of durvalumab.

PFS-6 is the primary endpoint of Cohorts B, B2, and B3, and is the percentage of subjects who have not progressed at 6 months, with PFS measured from the date of the first dose of study treatment to the date of earliest disease progression (PD) based on modified Response Assessment in Neuro-Oncology (RANO) criteria or to the date of death, if PD does not occur. Per the RANO criteria, PD indicates any new lesion or a 25% increase in sum of the products of perpendicular diameters of enhancing lesions, or clear clinical deterioration per the Investigator (Wen et al. J Clin Oncol 2010; 28(11):1963-72).

Outcome measures

Measure	Cohort A n=31 Participants Subjects with newly diagnosed unmethlyated MGMT GBM receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.	Cohort B2 n=33 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 n=33 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort C Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.
Progression-free Survival Rate at 6 Months (PFS-6) as Estimated Using the Kaplan-Meier Method (Cohorts B, B2, and B3)	19.4 percentage of participants Interval 9.3 to 32.1	15.2 percentage of participants Interval 6.7 to 26.8	17.2 percentage of participants Interval 7.7 to 29.7	—	—

PRIMARY outcome

Timeframe: Up to 6 months

Population: The population comprises all subjects who received any dose of durvalumab.

OS-6 is the primary endpoint of Cohort C and is the percentage of subjects who remain alive at 6 months, where OS is measured from the date of the first dose of study treatment until the recorded date of death or last follow-up. Subjects who are lost to follow-up at the time of the analysis will be censored on the date of last follow-up.

Outcome measures

Measure	Cohort A n=22 Participants Subjects with newly diagnosed unmethlyated MGMT GBM receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.	Cohort B2 Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort C Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.
Overall Survival Rate at 6 Months (OS-6) as Estimated Using the Kaplan-Meier Method (Cohort C)	36.4 percentage of participants Interval 23.5 to 49.3	—	—	—	—

SECONDARY outcome

Timeframe: Up to 15 months

Population: The population comprises all subjects who received any dose of durvalumab.

Toxicity is graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) are reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, magnetic resonance imaging, and any other medically indicated assessments, including subject interviews, from the time informed consent is signed through 90 days after the last dose of durvalumab. AEs are considered to be treatment emergent if they occur or worsen in severity after the first dose of study treatment.

Outcome measures

Measure	Cohort A n=40 Participants Subjects with newly diagnosed unmethlyated MGMT GBM receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.	Cohort B2 n=31 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 n=33 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 n=33 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort C n=22 Participants Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.
Number of Participants With Treatment-emergent Adverse Events Any TEAE	40 Participants	31 Participants	33 Participants	33 Participants	22 Participants
Number of Participants With Treatment-emergent Adverse Events Serious TEAE	26 Participants	18 Participants	11 Participants	15 Participants	14 Participants
Number of Participants With Treatment-emergent Adverse Events Treatment-related TEAE	37 Participants	26 Participants	30 Participants	31 Participants	17 Participants

SECONDARY outcome

Timeframe: Up to 15 months

Population: The population comprises all subjects who received any dose of durvalumab.

PFS is measured from the date of the first dose of study treatment to the date of earliest PD based on modified RANO criteria or to the date of death, if PD does not occur. Per the RANO criteria, PD indicates any new lesion or a 25% increase in sum of the products of perpendicular diameters of enhancing lesions, or clear clinical deterioration per the Investigator (Wen et al. J Clin Oncol 2010; 28(11):1963-72).

Outcome measures

Measure	Cohort A n=40 Participants Subjects with newly diagnosed unmethlyated MGMT GBM receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.	Cohort B2 n=31 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 n=33 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 n=33 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort C n=22 Participants Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.
Median PFS as Estimated Using the Kaplan-Meier Method	19.9 weeks Interval 16.0 to 32.3	13.0 weeks Interval 7.4 to 20.1	16.0 weeks Interval 11.9 to 16.1	15.7 weeks Interval 8.3 to 16.4	7.9 weeks Interval 5.3 to 8.6

SECONDARY outcome

Timeframe: Up to 36 months

Population: The population comprises all subjects who received any dose of durvalumab.

All subjects are followed for survival at least every 6 months for up to 3 years following initiation of study treatment. In Cohort A, OS is measured from the date of diagnosis until the recorded date of death or last follow-up. In Cohorts B, B2, B3, and C, OS is measured from the date of the first dose of study treatment until the recorded date of death or last follow-up. Subjects who remain alive or are lost to follow-up at the time of the analysis are censored on the date of last follow-up.

Outcome measures

Measure	Cohort A n=40 Participants Subjects with newly diagnosed unmethlyated MGMT GBM receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.	Cohort B2 n=31 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 n=33 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 n=33 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort C n=22 Participants Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.
Median OS as Estimated Using the Kaplan-Meier Method	64.8 weeks Interval 51.6 to 78.9	39.4 weeks Interval 23.7 to 64.3	37.3 weeks Interval 24.4 to 43.4	39.7 weeks Interval 26.9 to 47.4	19.3 weeks Interval 10.3 to 27.7

SECONDARY outcome

Timeframe: Up to 15 months

Population: The population comprises all subjects who received any dose of durvalumab.

Radiographic response is assessed by consistent imaging methods every (q) 8 to 9 weeks during study treatment administration. Response is categorized per the modified RANO criteria: complete response (CR) indicates no new lesions and disappearance of all disease sustained for ≥ 4 weeks; partial response (PR) indicates no new lesions, no progression of non-measureable disease, and ≥ 50% decrease from baseline in sum of products of perpendicular diameters of measurable lesions sustained for ≥ 4 weeks; stable disease (SD) indicates non-qualification for CR, PR, or progressive disease (PD); PD indicates any new lesion or a 25% increase in sum of the products of perpendicular diameters of enhancing lesions, or clear clinical deterioration per the Investigator (Wen et al. J Clin Oncol 2010; 28(11):1963-72).

Outcome measures

Measure	Cohort A n=40 Participants Subjects with newly diagnosed unmethlyated MGMT GBM receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.	Cohort B2 n=31 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 n=33 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 n=33 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort C n=22 Participants Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.
Number of Subjects With Best Overall Response CR	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Best Overall Response PR	4 Participants	4 Participants	3 Participants	3 Participants	0 Participants
Number of Subjects With Best Overall Response SD	26 Participants	12 Participants	20 Participants	18 Participants	6 Participants
Number of Subjects With Best Overall Response PD	9 Participants	15 Participants	10 Participants	11 Participants	14 Participants
Number of Subjects With Best Overall Response Unknown Response	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: Number of subjects who completed European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) at baseline and each visit.

Health-related quality of life was measured using the validated EORTC-QLQ-C30. Questionnaires may be completed by the subject or with the assistance of the examiner at baseline prior to initiation of study therapy, and then approximately every 8 weeks while on study treatment (prior to discussing treatment response at each visit, whenever possible).

All questions are answered using a categorical scale (1 = not at all; 2 = a little; 3 = quite a bit; 4 = very much for symptoms and 1= very poor; 7= excellent for global heath questions). Scores were linearly transformed to 0 to 100 scales so that higher scores represented a higher level of functioning.

Overall scores were calculated for each patient for each timepoint (Giesinger J et al Journal of Clinical Epidemiology. 2016 Jan;69:79-88). Mean change from baseline where baseline is the last non-missing value before the administration of MEDI4736 was reported.

Outcome measures

Measure	Cohort A n=40 Participants Subjects with newly diagnosed unmethlyated MGMT GBM receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.	Cohort B2 n=31 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 n=33 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 n=33 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort C n=22 Participants Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.
Mean Changes From Baseline in the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Week 9	-6.03 units on a scale Standard Deviation 19.53	-8.33 units on a scale Standard Deviation 26.16	-5.56 units on a scale Standard Deviation 21.80	-7.05 units on a scale Standard Deviation 20.78	-12.50 units on a scale Standard Deviation 24.30
Mean Changes From Baseline in the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Week 17	-2.0 units on a scale Standard Deviation 18.05	4.17 units on a scale Standard Deviation 27.46	-7.14 units on a scale Standard Deviation 26.53	-7.74 units on a scale Standard Deviation 18.62	-16.67 units on a scale Standard Deviation 6.80
Mean Changes From Baseline in the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Week 25	0.42 units on a scale Standard Deviation 15.64	10.42 units on a scale Standard Deviation 17.18	-3.70 units on a scale Standard Deviation 31.49	-8.33 units on a scale Standard Deviation 19.54	—
Mean Changes From Baseline in the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Week 33	-6.25 units on a scale Standard Deviation 15.27	30.56 units on a scale Standard Deviation 20.97	2.08 units on a scale Standard Deviation 34.94	11.11 units on a scale Standard Deviation 12.73	—
Mean Changes From Baseline in the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Week 41	0.0 units on a scale Standard Deviation 11.79	19.44 units on a scale Standard Deviation 12.73	16.67 units on a scale	-2.08 units on a scale Standard Deviation 31.46	—
Mean Changes From Baseline in the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Week 49	3.57 units on a scale Standard Deviation 13.49	16.67 units on a scale Standard Deviation 16.67	4.17 units on a scale Standard Deviation 17.68	8.33 units on a scale	—

SECONDARY outcome

Timeframe: Up to 12 months

Population: Number of subjects who completed EORTC Brain Cancer Quality of Life Questionnaire (EORTC-QLQ-BN-20) at baseline and each visit.

Health-related quality of life was measured using an EORTC quality of life questionnaire designed specifically for subjects with brain tumors (BN-20). Questionnaires may be completed by the subject or with the assistance of the examiner at baseline prior to initiation of study therapy, and then approximately every 8 weeks while on study treatment (prior to discussing treatment response at each visit, whenever possible). All single questions are answered using a categorical scale (e.g., 1 = not at all; 2 = a little; 3 = quite a bit; 4 = very much) and linearly transformed to 0 to 100 scales with higher scores for a symptom scale representing higher level of symptoms. The evaluation of HRQoL at each timepoint was measured by mean changes from baseline where baseline is the last non-missing value before the administration of MEDI4736 was reported.

Outcome measures

Measure	Cohort A n=40 Participants Subjects with newly diagnosed unmethlyated MGMT GBM receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.	Cohort B2 n=31 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 n=33 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 n=33 Participants Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort C n=22 Participants Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.
Mean Changes From Baseline in the EORTC Brain Cancer Quality of Life Questionnaire (EORTC-QLQ-BN-20) Week 9	3.63 units on a scale Standard Deviation 8.28	5.62 units on a scale Standard Deviation 16.46	4.26 units on a scale Standard Deviation 15.95	3.50 units on a scale Standard Deviation 15.99	-2.17 units on a scale Standard Deviation 17.14
Mean Changes From Baseline in the EORTC Brain Cancer Quality of Life Questionnaire (EORTC-QLQ-BN-20) Week 17	0.85 units on a scale Standard Deviation 11.71	0.21 units on a scale Standard Deviation 8.93	-2.55 units on a scale Standard Deviation 18.17	-4.06 units on a scale Standard Deviation 14.33	9.17 units on a scale Standard Deviation 3.54
Mean Changes From Baseline in the EORTC Brain Cancer Quality of Life Questionnaire (EORTC-QLQ-BN-20) Week 25	-0.82 units on a scale Standard Deviation 11.12	-3.33 units on a scale Standard Deviation 8.66	3.27 units on a scale Standard Deviation 18.46	-1.37 units on a scale Standard Deviation 11.80	—
Mean Changes From Baseline in the EORTC Brain Cancer Quality of Life Questionnaire (EORTC-QLQ-BN-20) Week 33	6.46 units on a scale Standard Deviation 16.94	-4.44 units on a scale Standard Deviation 10.05	-9.39 units on a scale Standard Deviation 16.32	-17.28 units on a scale Standard Deviation 10.64	—
Mean Changes From Baseline in the EORTC Brain Cancer Quality of Life Questionnaire (EORTC-QLQ-BN-20) Week 41	1.94 units on a scale Standard Deviation 18.72	-5.83 units on a scale Standard Deviation 15.32	5.00 units on a scale	-3.60 units on a scale Standard Deviation 10.38	—
Mean Changes From Baseline in the EORTC Brain Cancer Quality of Life Questionnaire (EORTC-QLQ-BN-20) Week 49	5.56 units on a scale Standard Deviation 22.08	-1.11 units on a scale Standard Deviation 5.36	5.83 units on a scale Standard Deviation 5.89	2.46 units on a scale	—

Adverse Events

Cohort A

Serious events: 26 serious events

Other events: 40 other events

Deaths: 10 deaths

Cohort B

Serious events: 18 serious events

Other events: 31 other events

Deaths: 4 deaths

Cohort B2

Serious events: 11 serious events

Other events: 33 other events

Deaths: 6 deaths

Cohort B3

Serious events: 15 serious events

Other events: 33 other events

Deaths: 3 deaths

Cohort C

Serious events: 14 serious events

Other events: 22 other events

Deaths: 7 deaths

Serious adverse events

Measure	Cohort A n=40 participants at risk Subjects with newly diagnosed unmethlyated MGMT GBM receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.	Cohort B n=31 participants at risk Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) as monotherapy.	Cohort B2 n=33 participants at risk Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 n=33 participants at risk Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort C n=22 participants at risk Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.
Nervous system disorders Headache	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Haemorrhage intracranial	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm progression	17.5% 7/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.9% 4/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 6/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	27.3% 6/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Cognitive disorder	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Renal and urinary disorders Urinary incontinence	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Gait disturbance	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Hemiparesis	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	16.1% 5/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Injury, poisoning and procedural complications Overdose	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Surgical and medical procedures Craniotomy	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.7% 3/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Hydrocephalus	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Convulsion	22.5% 9/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.9% 4/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	22.7% 5/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Somnolence	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Colitis	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Aphasia	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Asthenia	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Brain oedema	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Psychiatric disorders Confusional state	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Dehydration	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Dyspepsia	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Encephalopathy	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Injury, poisoning and procedural complications Fall	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Fatigue	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Lung infection	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Nausea	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Pyrexia	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Vomiting	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.7% 3/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Eye disorders Blindness	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Cerebrovascular accident	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Dysphagia	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Psychiatric disorders Mental status changes	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Neurological decompensation	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Surgical and medical procedures Tumour excision	10.0% 4/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Cardiac disorders Atrial flutter	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Biopsy brain	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Dysarthria	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Neurologic neglect syndrome	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Pneumonia	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Skin and subcutaneous tissue disorders Rash	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Renal and urinary disorders Urinary retention	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Wound infection	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Abdominal pain	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hyperglycaemia	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Influenza	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Partial seizures	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Syncope	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Psychiatric disorders Irritability	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Psychiatric disorders Pyschotic disorder	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Psychiatric disorders Suicidal ideation	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hyponatraemia	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Diarrhoea	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Faecal incontinence	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Infection	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Lethargy	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Central nervous system lesion	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Drowning	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Mass	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Cardiac disorders Cardiac arrest	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Psychiatric disorders Hallucination, olfactory	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Generalised oedema	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Urinary tract infection	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Small intestinal obstruction	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Surgical and medical procedures Ventriculo-peritoneal shunt	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Renal and urinary disorders Nephritis	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.

Other adverse events

Measure	Cohort A n=40 participants at risk Subjects with newly diagnosed unmethlyated MGMT GBM receive durvalumab (10 mg/kg IV Q2W) + standard radiotherapy (2 Gy/day x 5 days per week, for a total of 60 Gy over 30 fractions per local guidelines). On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.	Cohort B n=31 participants at risk Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) as monotherapy.	Cohort B2 n=33 participants at risk Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort B3 n=33 participants at risk Bevacizumab-naïve subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + bevacizumab (3 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.	Cohort C n=22 participants at risk Bevacizumab-refractory subjects with recurrent GBM receive durvalumab (10 mg/kg IV Q2W) + continued bevacizumab (10 mg/kg IV Q2W). Durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.
Gastrointestinal disorders Abdominal pain	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.7% 3/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Alanine aminotransferase increased	20.0% 8/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.9% 4/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 6/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	27.3% 9/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 4/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Blood and lymphatic system disorders Anaemia	10.0% 4/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Aphasia	27.5% 11/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.7% 3/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 6/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	21.2% 7/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	27.3% 6/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 5/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	24.2% 8/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	21.2% 7/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Aspartate aminotransferase increased	27.5% 11/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.9% 4/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	24.2% 8/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Asthenia	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Ataxia	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.7% 3/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Back pain	12.5% 5/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Balance disorder	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Blood alkaline phosphatase increased	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Blood thyroid stimulating hormone decreased	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.7% 3/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Cognitive disorder	15.0% 6/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 4/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Psychiatric disorders Confusional state	15.0% 6/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	16.1% 5/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	27.3% 6/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Constipation	25.0% 10/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	19.4% 6/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	21.2% 7/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	13.6% 3/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Convulsion	12.5% 5/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 6/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 8/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	16.1% 5/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 6/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 6/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	22.7% 5/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Psychiatric disorders Depression	20.0% 8/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 6/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Diarrhoea	25.0% 10/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.7% 3/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 6/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	24.2% 8/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Dizziness	25.0% 10/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	22.6% 7/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 6/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Skin and subcutaneous tissue disorders Dry skin	12.5% 5/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Dysgeusia	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Dysarthria	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Dyspepsia	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.0% 4/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Injury, poisoning and procedural complications Fall	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	16.1% 5/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	27.3% 9/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	13.6% 3/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Fatigue	72.5% 29/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	32.3% 10/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	39.4% 13/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	54.5% 18/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	31.8% 7/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Gait disturbance	32.5% 13/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	32.3% 10/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	33.3% 11/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	22.7% 5/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Headache	47.5% 19/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	38.7% 12/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	27.3% 9/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	27.3% 9/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	36.4% 8/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Hemiparesis	10.0% 4/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.7% 3/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	36.4% 12/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 4/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Vascular disorders Hot flush	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hyperglycaemia	22.5% 9/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	19.4% 6/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	24.2% 8/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	22.7% 5/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Endocrine disorders Hyperthyroidism	10.0% 4/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hypokalaemia	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hyponatraemia	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.7% 3/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	22.7% 5/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Endocrine disorders Hypothyroidism	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.7% 3/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Lymphocyte count decreased	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	16.1% 5/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 4/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Memory impairment	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	22.6% 7/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Renal and urinary disorders Micturition urgency	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Muscular weakness	12.5% 5/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Myalgia	15.0% 6/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.7% 3/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Nausea	30.0% 12/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	19.4% 6/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Renal and urinary disorders Nephrolithiasis	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Non-cardiac chest pain	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Oedema peripheral	10.0% 4/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Paraesthesia	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.9% 4/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Platelet count decreased	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.9% 4/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Somnolence	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Blood and lymphatic system disorders Thrombocytopenia	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Upper respiratory tract infection	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.9% 4/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Renal and urinary disorders Urinary incontinence	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Visual field defect	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.7% 3/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Vomiting	10.0% 4/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Weight decreased	12.5% 5/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Psychiatric disorders Agitation	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Skin and subcutaneous tissue disorders Alopecia	50.0% 20/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Amylase increased	17.5% 7/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 6/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 6/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Psychiatric disorders Anxiety	17.5% 7/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Blood bilirubin increased	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Blood lactate dehydrogenase increased	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Chills	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Injury, poisoning and procedural complications Contusion	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Decreased appetite	20.0% 8/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Eye disorders Dry eye	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Dysphonia	10.0% 4/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	36.4% 12/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	27.3% 9/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Facial paresis	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Faecal incontinence	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Renal and urinary disorders Haematuria	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Vascular disorders Hypertension	15.0% 6/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	24.2% 8/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hypoalbuminaemia	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hypocalcaemia	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hypoglycaemia	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Psychiatric disorders Insomnia	27.5% 11/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Eye disorders Lacrimation increased	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Blood and lymphatic system disorders Leukopenia	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Lipase increased	27.5% 11/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 6/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 6/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	21.2% 7/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Nasopharyngitis	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Neutrophil count decreased	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Renal and urinary disorders Proteinuria	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Skin and subcutaneous tissue disorders Pruritus	10.0% 4/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Skin and subcutaneous tissue disorders Rash	22.5% 9/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Skin infection	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Sneezing	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Thyroxine free decreased	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Urinary tract infection	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	15.2% 5/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Eye disorders Vision blurred	12.5% 5/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations White blood cell count decreased	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Cardiac disorders Bradycardia	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Catheter site pain	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Endocrine disorders Cushingoid	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Dysphagia	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	18.2% 4/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Endocrine disorders Endocrine disorder	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Hypoaesthesia	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Renal and urinary disorders Incontinence	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Injection site bruising	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Lethargy	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Neck pain	17.5% 7/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Blood and lymphatic system disorders Neutropenia	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 2/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	9.1% 3/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Peripheral motor neuropathy	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Renal and urinary disorders Pollakiuria	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Stomatitis	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Tremor	15.0% 6/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Weight increased	2.5% 1/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	12.1% 4/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations White blood cell count increased	0.00% 0/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Psychiatric disorders Irritability	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.1% 2/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Pyrexia	10.0% 4/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.5% 2/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Amnesia	10.0% 4/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Disturbance in attention	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Nervous system disorders Peripheral sensory neuropathy	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
General disorders Face oedema	15.0% 6/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Gastrointestinal disorders Dry mouth	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Haematocrit decreased	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Investigations Transaminases increased	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Musculoskeletal and connective tissue disorders Muscle spasms	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Skin and subcutaneous tissue disorders Dermatitis acneiform	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Skin and subcutaneous tissue disorders Pain of skin	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Sinusitis	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Infections and infestations Oral candidiasis	10.0% 4/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Eye disorders Eye pain	7.5% 3/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.0% 1/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Ear and labyrinth disorders Tinnitus	10.0% 4/40 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	3.2% 1/31 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/33 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	4.5% 1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., up to 15 months after the first dose of study treatment) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.

Additional Information

Jonathan Skipper PhD

Ludwig Institute for Cancer Research

Phone: (212) 450-1539

Email: jskipper@lcr.org

Results disclosure agreements

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

Restriction type: LTE60