Trial Outcomes & Findings for A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers (NCT NCT02643303)

Last Updated: 2022-12-02

Results Overview

Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 90 days after the last dose of study treatment. Treatment-emergent AEs were those that occurred or worsened after administration of the first dose of study treatment.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

58 participants

Primary outcome timeframe

up to 15 months

Results posted on

2022-12-02

Participant Flow

58 subjects were enrolled and 56 treated with at least one dose of study treatment.

The Phase 1 Cohort 1C dosing regimen was used in Phase 2 without any dose modifications. As indicated in the protocol, the subjects enrolled in Cohort 1C are included in the appropriate Phase 2 cohort based on tumor type. For this reason, Cohort 1C is not presented separately.

Participant milestones

Participant milestones
Measure	Phase 1, Cohort 1A Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC	Phase 1, Cohort 1B Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Sarcoma Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Merkel Cell Carcinoma Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Solid Tumors With Accessible Masses Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Overall Study STARTED	4	5	1	15	7	4	10	3	7
Overall Study COMPLETED	0	0	0	2	0	0	1	0	0
Overall Study NOT COMPLETED	4	5	1	13	7	4	9	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1, Cohort 1A Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC	Phase 1, Cohort 1B Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Sarcoma Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Merkel Cell Carcinoma Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Solid Tumors With Accessible Masses Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Overall Study Progressive Disease	4	4	1	12	6	4	8	2	6
Overall Study Adverse Event	0	1	0	0	1	0	0	0	0
Overall Study Withdrawal by Subject	0	0	0	1	0	0	1	1	1

Baseline Characteristics

A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1, Cohort 1A n=4 Participants Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC	Phase 1, Cohort 1B n=5 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma n=1 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer n=15 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Sarcoma n=7 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Merkel Cell Carcinoma n=4 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies n=10 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases n=3 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Solid Tumors With Accessible Masses n=7 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Total n=56 Participants Total of all reporting groups
Age, Continuous	52.5 years n=5 Participants	55 years n=7 Participants	66 years n=5 Participants	59 years n=4 Participants	51 years n=21 Participants	66 years n=8 Participants	64 years n=8 Participants	54 years n=24 Participants	58 years n=42 Participants	58 years n=42 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	15 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	6 Participants n=8 Participants	0 Participants n=24 Participants	4 Participants n=42 Participants	36 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=8 Participants	4 Participants n=8 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	20 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	14 Participants n=4 Participants	7 Participants n=21 Participants	4 Participants n=8 Participants	10 Participants n=8 Participants	3 Participants n=24 Participants	6 Participants n=42 Participants	54 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	7 Participants n=42 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	11 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=8 Participants	7 Participants n=8 Participants	3 Participants n=24 Participants	6 Participants n=42 Participants	45 Participants n=42 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants
Region of Enrollment United States	4 participants n=5 Participants	5 participants n=7 Participants	1 participants n=5 Participants	15 participants n=4 Participants	7 participants n=21 Participants	4 participants n=8 Participants	10 participants n=8 Participants	3 participants n=24 Participants	7 participants n=42 Participants	56 participants n=42 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ECOG PS 0	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	1 Participants n=24 Participants	4 Participants n=42 Participants	23 Participants n=42 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ECOG PS 1	2 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	6 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	33 Participants n=42 Participants

PRIMARY outcome

Timeframe: up to 15 months

Population: All subjects who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Phase 1, Cohort 1A n=4 Participants Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC	Phase 1, Cohort 1B n=5 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma n=1 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer n=15 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Sarcoma n=7 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Merkel Cell Carcinoma n=4 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies n=10 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases n=3 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Solid Tumors With Accessible Masses n=7 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Number of Subjects with TEAEs	4 Participants	5 Participants	1 Participants	15 Participants	7 Participants	4 Participants	10 Participants	3 Participants	7 Participants
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Number of Subjects with Treatment-Related TEAEs (TRAEs)	4 Participants	4 Participants	1 Participants	13 Participants	6 Participants	3 Participants	10 Participants	1 Participants	7 Participants
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Number of Subjects with Serious TRAEs	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Number of Subjects with Dose-Limiting Toxicities (DLTs)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Number of Subjects who Died on Study	0 Participants	2 Participants	0 Participants	3 Participants	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: up to 15 months

Population: All subjects who had at least one dose of study medication and one baseline and at least one post-baseline disease assessment.

Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. Per irRECIST, measurable lesions were categorized as follows: Complete Response (irCR): Complete disappearance of all target lesions; Partial Response (irPR): ≥ 30% decrease from baseline in the Total Measured Tumor Burden (TMTB); Progressive Disease (irPD): ≥ 20% increase from nadir in Total Measured Tumor Burden (TMTB); Stable Disease (irSD): not meeting above criteria.

Outcome measures

Outcome measures
Measure	Phase 1, Cohort 1A n=4 Participants Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC	Phase 1, Cohort 1B n=4 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma n=1 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer n=14 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Sarcoma n=7 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Merkel Cell Carcinoma n=4 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies n=9 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases n=2 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Solid Tumors With Accessible Masses n=6 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Number of Subjects With Best Overall Tumor Response by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) irCR	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Best Overall Tumor Response by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) irPR	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Best Overall Tumor Response by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) irSD	2 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	3 Participants	0 Participants	3 Participants
Number of Subjects With Best Overall Tumor Response by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) irPD	1 Participants	4 Participants	1 Participants	9 Participants	6 Participants	4 Participants	6 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: up to 15 months

Population: All subjects who had at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Phase 1, Cohort 1A n=4 Participants Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC	Phase 1, Cohort 1B n=5 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma n=1 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer n=15 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Sarcoma n=7 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Merkel Cell Carcinoma n=4 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies n=10 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases n=3 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Solid Tumors With Accessible Masses n=7 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Median Progression-free Survival (PFS) by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) as Estimated Using the Kaplan-Meier Method	157 days Interval 82.0 to The upper limit of the confidence interval was not estimable due to the small number of events.	44 days Interval 21.0 to The upper limit of the confidence interval was not estimable due to the small number of events.	85 days The upper and lower limits of the confidence interval were not estimable due to the small number of events.	85 days Interval 42.0 to 225.0	44 days Interval 9.0 to 83.0	68 days Interval 37.0 to The upper limit of the confidence interval was not estimable due to the small number of events.	82 days Interval 26.0 to 127.0	43 days Interval 24.0 to The upper limit of the confidence interval was not estimable due to the small number of events.	84 days Interval 37.0 to The upper limit of the confidence interval was not estimable due to the small number of events.

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: All subjects who had at least one dose of study medication and one baseline and at least one post-baseline disease assessment.

Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. Per irRECIST, measurable lesions were categorized as follows: Complete Response (irCR): Complete disappearance of all target lesions; Partial Response (irPR): ≥ 30% decrease from baseline in the Total Measurable Tumor Burden (TMTB); Progressive Disease (irPD): ≥ 20% increase from nadir in Total Measured Tumor Burden (TMTB); Stable Disease (irSD): not meeting above criteria. Overall Disease Control Rate was defined as the percentage of subjects who had irSD for at least 6 months, or irPR or irCR over a period of at least 4 weeks. Subjects who dropped out prior to meeting the responder criteria were considered non-responders.

Outcome measures

Outcome measures
Measure	Phase 1, Cohort 1A n=4 Participants Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC	Phase 1, Cohort 1B n=4 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma n=1 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer n=14 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Sarcoma n=7 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Merkel Cell Carcinoma n=4 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies n=9 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases n=2 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Solid Tumors With Accessible Masses n=6 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Overall Disease Control Rate as Measured by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)	1 Participants	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 13 months

Population: All subjects who had at least one dose of study medication and one baseline and at least one post-baseline disease assessment.

Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. Per RECIST 1.1, target lesions are categorized as follows: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions or presence of new lesions; Stable Disease (SD): small changes that did not meet above criteria.

Outcome measures

Outcome measures
Measure	Phase 1, Cohort 1A n=4 Participants Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC	Phase 1, Cohort 1B n=4 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma n=1 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer n=14 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Sarcoma n=7 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Merkel Cell Carcinoma n=4 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies n=9 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases n=2 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Solid Tumors With Accessible Masses n=6 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Number of Subjects With Best Overall Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) CR	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Best Overall Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) PR	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Best Overall Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) SD	2 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	3 Participants	0 Participants	3 Participants
Number of Subjects With Best Overall Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) PD	1 Participants	4 Participants	1 Participants	9 Participants	7 Participants	4 Participants	6 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 15 months

Population: All subjects who had at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Phase 1, Cohort 1A n=4 Participants Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC	Phase 1, Cohort 1B n=5 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma n=1 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer n=15 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Sarcoma n=7 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Merkel Cell Carcinoma n=4 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies n=10 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases n=3 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Solid Tumors With Accessible Masses n=7 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Median PFS by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Estimated Using the Kaplan-Meier Method	157 days Interval 82.0 to Upper limit of confidence interval was not estimable due to the small number of events.	44 days Interval 21.0 to Upper limit of confidence interval was not estimable due to the small number of events.	85 days Upper and lower limits of confidence interval were not estimable due to the small number of events.	85 days Interval 42.0 to 225.0	44 days Interval 9.0 to 83.0	68 days Interval 37.0 to Upper limit of confidence interval was not estimable due to the small number of events.	82 days Interval 26.0 to 127.0	43 days Interval 24.0 to Upper limit of confidence interval was not estimable due to the small number of events.	84 days Interval 37.0 to Upper limit of confidence interval was not estimable due to the small number of events.

SECONDARY outcome

Timeframe: up to 24 weeks

Population: All subjects who had at least one dose of study medication and one baseline and at least one post-baseline disease assessment.

Outcome measures

Outcome measures
Measure	Phase 1, Cohort 1A n=4 Participants Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC	Phase 1, Cohort 1B n=4 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma n=1 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer n=14 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Sarcoma n=7 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Merkel Cell Carcinoma n=4 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies n=9 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases n=2 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Solid Tumors With Accessible Masses n=6 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Overall Disease Control Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)	1 Participants	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 5 years

Population: All subjects that had at least one study treatment.

After completion of treatment, all subjects were followed for survival every 3 months for 2 years after completion of treatment; then every 6 months until 5 years from study entry; then yearly until 10 years from study entry. OS was measured from the date of the first dose of study treatment to the date of death or last follow-up. Subjects lost to follow-up were censored on the date when they were last known to be alive. Per protocol amendment 6.0, all post study follow-up for the collection of survival data was discontinued as of February 28, 2022. The last collection of survival data was on February 23, 2022.

Outcome measures

Outcome measures
Measure	Phase 1, Cohort 1A n=4 Participants Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC	Phase 1, Cohort 1B n=5 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma n=1 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer n=15 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Sarcoma n=7 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Merkel Cell Carcinoma n=4 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies n=10 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases n=3 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Solid Tumors With Accessible Masses n=7 Participants Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method	1238 days Interval 266.0 to Upper limit of confidence interval was not estimable due to the small number of events.	129 days Interval 26.0 to Upper limit of confidence interval was not estimable due to the small number of events.	338 days Upper and lower limits of confidence interval were not estimable due to the small number of events.	326 days Interval 68.0 to Upper limit of confidence interval was not estimable due to the small number of events.	300 days Interval 64.0 to 370.0	224 days Interval 74.0 to Upper limit of confidence interval was not estimable due to the small number of events.	202 days Interval 51.0 to Upper limit of confidence interval was not estimable due to the small number of events.	43 days Interval 39.0 to Upper limit of confidence interval was not estimable due to the small number of events.	565 days Interval 264.0 to Upper limit of confidence interval was not estimable due to the small number of events.

Adverse Events

Phase 1, Cohort 1A

Serious events: 0 serious events

Other events: 4 other events

Deaths: 3 deaths

Phase 1, Cohort 1B

Serious events: 3 serious events

Other events: 5 other events

Deaths: 5 deaths

Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer

Serious events: 4 serious events

Other events: 15 other events

Deaths: 9 deaths

Cohort 1C + Phase 2; Sarcoma

Serious events: 3 serious events

Other events: 7 other events

Deaths: 6 deaths

Cohort 1C + Phase 2; Merkel Cell Carcinoma

Serious events: 2 serious events

Other events: 4 other events

Deaths: 4 deaths

Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies

Serious events: 3 serious events

Other events: 10 other events

Deaths: 6 deaths

Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Cohort 1C + Phase 2; Solid Tumors With Accessible Masses

Serious events: 2 serious events

Other events: 7 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1, Cohort 1A n=4 participants at risk Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC	Phase 1, Cohort 1B n=5 participants at risk Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma n=1 participants at risk Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer n=15 participants at risk Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Sarcoma n=7 participants at risk Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Merkel Cell Carcinoma n=4 participants at risk Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies n=10 participants at risk Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases n=3 participants at risk Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Solid Tumors With Accessible Masses n=7 participants at risk Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Eyelid ptosis	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 2/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Intestinal obstruction	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Sepsis	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	66.7% 2/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Hypercalcaemia	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Myositis	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 3/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	66.7% 2/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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) Metastases to bone	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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) Neoplasm progression	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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) Tumour haemorrhage	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Acute kidney injury	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Pleural effusion	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Hypotension	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Superior vena cava syndrome	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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

Other adverse events
Measure	Phase 1, Cohort 1A n=4 participants at risk Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC	Phase 1, Cohort 1B n=5 participants at risk Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma n=1 participants at risk Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer n=15 participants at risk Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Sarcoma n=7 participants at risk Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Merkel Cell Carcinoma n=4 participants at risk Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies n=10 participants at risk Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases n=3 participants at risk Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	Cohort 1C + Phase 2; Solid Tumors With Accessible Masses n=7 participants at risk Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Blood and lymphatic system disorders Anaemia	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	60.0% 3/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	13.3% 2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	42.9% 3/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	30.0% 3/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Lymph node pain	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Tachycardia	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	13.3% 2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Palpitations	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Pericardial effusion	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Myocarditis	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Ear pain	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	50.0% 2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Excess cerumen production	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 swelling	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Eyelid oedema	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Photophobia	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Visual impairment	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Vitreous floaters	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	100.0% 1/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	46.7% 7/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 2/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	57.1% 4/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	60.0% 3/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	100.0% 4/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	50.0% 5/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	26.7% 4/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	50.0% 2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 2/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	28.6% 2/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	40.0% 2/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	100.0% 1/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 3/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 2/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 2/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 distention	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	13.3% 2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 upper	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Chapped lips	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 lower	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Anal incontinence	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Ascites	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Flatulence	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Gastrointestinal pain	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Retching	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Toothache	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	75.0% 3/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	40.0% 2/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	100.0% 1/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	46.7% 7/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	75.0% 3/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	80.0% 8/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	100.0% 3/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	71.4% 5/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	53.3% 8/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	28.6% 2/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	50.0% 2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	40.0% 4/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 pain	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	40.0% 2/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	100.0% 1/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	46.7% 7/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	42.9% 3/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	75.0% 3/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 3/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	57.1% 4/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	50.0% 2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 2/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	28.6% 2/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Influenza like illness	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	26.7% 4/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	28.6% 2/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	50.0% 2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	28.6% 2/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 2/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 reaction	100.0% 4/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Malaise	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	13.3% 2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Pain	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 2/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Chest pain	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 erythema	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Early satiety	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 haemorrhage	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 inflammation	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 swelling	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Localized oedema	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Peripheral swelling	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Puncture site haemorrhage	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Puncture site pain	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	13.3% 2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Candida infection	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	50.0% 2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Bronchitis	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Diverticulitis	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Ear infection	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Gastroenteritis	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Soft tissue infection	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Vaginal infection	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	13.3% 2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Infusion related reaction	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Post procedural contusion	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Post procedural haemorrhage	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Procedural pain	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Sunburn	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	13.3% 2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	66.7% 2/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	100.0% 1/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	50.0% 2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 creatinine increased	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Activated partial thromboplastin time prolonged	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	100.0% 1/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 cortisol increased	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 magnesium decreased	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 pressure increased	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Hepatic enzyme increased	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Troponin increased	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Electrocardiogram QT prolonged	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	50.0% 2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	50.0% 5/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	28.6% 2/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 2/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Hypomagnesaemia	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Hypercalcaemia	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	100.0% 1/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Hypophosphataemia	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Malnutrition	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	100.0% 1/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	28.6% 2/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	50.0% 2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	30.0% 3/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	50.0% 2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	57.1% 4/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	28.6% 2/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 2/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	57.1% 4/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 chest pain	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	13.3% 2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 3/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Bone pain	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Joint swelling	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	28.6% 2/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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) Tumour pain	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	28.6% 2/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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) Tumour haemorrhage	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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) Tumour exudation	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 3/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	28.6% 2/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	50.0% 2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	40.0% 4/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 5/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	50.0% 2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Neuropathy peripheral	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	13.3% 2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 postural	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Hypersomnia	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Myasthenia gravis	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	40.0% 2/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	66.7% 2/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Delerium	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Acute kidney injury	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Hydronephrosis	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Reproductive system and breast disorders Breast pain	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Reproductive system and breast disorders Breast swelling	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Reproductive system and breast disorders Vulvovaginal discomfort	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	100.0% 1/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 3/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	28.6% 2/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	30.0% 3/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	28.6% 2/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	13.3% 2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	50.0% 2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	30.0% 3/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	50.0% 2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	28.6% 2/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	13.3% 2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	28.6% 2/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Haemoptysis	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Rhinitis allergic	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Productive cough	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Tonsillar hypertrophy	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Vocal cord disorder	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Wheezing	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	100.0% 1/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 3/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 2/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	28.6% 2/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	13.3% 2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	50.0% 2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Erythema	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Skin lesion	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Blister	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Lichenoid keratosis	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Night sweats	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 generalized	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Abscess drainage	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Post procedural drainage	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Hypotension	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 2/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Deep vein thrombosis	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	14.3% 1/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Embolism	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	25.0% 1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Flushing	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	6.7% 1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Lymphoedema	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	20.0% 1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 Fibrillation	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/1 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	10.0% 1/10 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.	0.00% 0/7 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years. AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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

Ludwig Institute for Cancer Research

Phone: 12124501539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place