Trial Outcomes & Findings for Veliparib With or Without Radiation Therapy, Carboplatin, and Paclitaxel in Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery (NCT NCT01386385)

Last Updated: 2025-11-14

Results Overview

DLTs will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. DLTs must be attributable (probably, possibly, definitely related) to the study regimen and only occur during RT or 2 weeks after completing RT. DLTs are defined as: 1. Radiation esophagitis or dermatitis radiation Grade 3 that lasts \> 7 consecutive days or Grade 4 2. Grade 4 neutropenia for \> 7 days or neutropenic fever ( ANC \<500 and temperature \>= 38.5 oC) 3. Grade 4 thrombocytopenia 4. Grade 4 nausea/vomiting despite appropriate antiemetic therapy 5. Delays in radiotherapy or chemotherapy or ABT-888 due to toxicity of \> 3 weeks 6. All other non-hematologic toxicities \>= Grade 3, except * anorexia * fatigue * infection without neutropenia * Grade 3 AST/ALT elevations \<= 7 days, infusion reactions * Grade 3 or 4 lymphopenia * Grade 3 or 4 electrolyte abnormalities that are corrected to \<=Grade 2 in \< 48 hours * Grade 3 dehydration lasting \< 7 days

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

53 participants

Primary outcome timeframe

9 weeks

Results posted on

2025-11-14

Participant Flow

In phase I, 21 participants were enrolled (8 on 40mg cohort, 7 on 80mg cohort and 6 on 120mg cohort separately). All 21 participants met the eligibility criterial. 14 of 21 participants later went on to consolidation therapy. In phase II, 32 participants were enrolled. 1 was ineligible and thus excluded from analysis. 18 of 31 eligible participants were randomized to veliparib arm and 13 participants to the placebo arm. 23 of 31 eligible participants later on went on to consolidation therapy

Participant milestones

Participant milestones
Measure	Phase I 40 mg Veliparib Cohort Participants undergo 3D-CRT and receive 40 mg veliparib, carboplatin, and paclitaxel during RT	Phase I Consolidation 40mg Cohort Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles	Phase I 80 mg Veliparib Cohort Participants undergo 3D-CRT and receive 80 mg veliparib, carboplatin, and paclitaxel during RT	Phase I Consolidation 80mg Cohort Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase I 120 mg Veliparib Cohort Participants undergo 3D-CRT and receive 120 mg veliparib, carboplatin, and paclitaxel during RT.	Phase I Consolidation 120mg Cohort Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase II Arm I (RT, Veliparib, Carboplatin, Paclitaxel) Participants undergo 3D-CRT and receive 120mg veliparib, carboplatin, and paclitaxel During consolidation, participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase II Arm II (3D-CRT, Placebo, Carboplatin, Paclitaxel) Participants undergo 3D-CRT and receive placebo PO BID, carboplatin and paclitaxel. During consolidation, participants receive 80 mg placebo (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
Phase I 40mg: Concurrent CRT STARTED	8	0	0	0	0	0	0	0
Phase I 40mg: Concurrent CRT COMPLETED	6	0	0	0	0	0	0	0
Phase I 40mg: Concurrent CRT NOT COMPLETED	2	0	0	0	0	0	0	0
Phase I 40mg: Consolidation Therapy STARTED	0	4	0	0	0	0	0	0
Phase I 40mg: Consolidation Therapy COMPLETED	0	4	0	0	0	0	0	0
Phase I 40mg: Consolidation Therapy NOT COMPLETED	0	0	0	0	0	0	0	0
Phase I 80mg: Concurrent CRT STARTED	0	0	7	0	0	0	0	0
Phase I 80mg: Concurrent CRT COMPLETED	0	0	5	0	0	0	0	0
Phase I 80mg: Concurrent CRT NOT COMPLETED	0	0	2	0	0	0	0	0
Phase I 80mg: Consolidation Therapy STARTED	0	0	0	5	0	0	0	0
Phase I 80mg: Consolidation Therapy COMPLETED	0	0	0	5	0	0	0	0
Phase I 80mg: Consolidation Therapy NOT COMPLETED	0	0	0	0	0	0	0	0
Phase I 120mg: Concurrent CRT STARTED	0	0	0	0	6	0	0	0
Phase I 120mg: Concurrent CRT COMPLETED	0	0	0	0	5	0	0	0
Phase I 120mg: Concurrent CRT NOT COMPLETED	0	0	0	0	1	0	0	0
Phase I 120mg: Consolidation Therapy STARTED	0	0	0	0	0	5	0	0
Phase I 120mg: Consolidation Therapy COMPLETED	0	0	0	0	0	5	0	0
Phase I 120mg: Consolidation Therapy NOT COMPLETED	0	0	0	0	0	0	0	0
Phase II Concurrent CRT STARTED	0	0	0	0	0	0	18	13
Phase II Concurrent CRT COMPLETED	0	0	0	0	0	0	12	10
Phase II Concurrent CRT NOT COMPLETED	0	0	0	0	0	0	6	3
Phase II: Consolidation Therapy STARTED	0	0	0	0	0	0	13	10
Phase II: Consolidation Therapy COMPLETED	0	0	0	0	0	0	8	8
Phase II: Consolidation Therapy NOT COMPLETED	0	0	0	0	0	0	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I 40 mg Veliparib Cohort Participants undergo 3D-CRT and receive 40 mg veliparib, carboplatin, and paclitaxel during RT	Phase I 80 mg Veliparib Cohort Participants undergo 3D-CRT and receive 80 mg veliparib, carboplatin, and paclitaxel during RT	Phase I 120 mg Veliparib Cohort Participants undergo 3D-CRT and receive 120 mg veliparib, carboplatin, and paclitaxel during RT.	Phase II Arm I (RT, Veliparib, Carboplatin, Paclitaxel) Participants undergo 3D-CRT and receive 120mg veliparib, carboplatin, and paclitaxel During consolidation, participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase II Arm II (3D-CRT, Placebo, Carboplatin, Paclitaxel) Participants undergo 3D-CRT and receive placebo PO BID, carboplatin and paclitaxel. During consolidation, participants receive 80 mg placebo (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
Phase I 40mg: Concurrent CRT Progression/relapse	1	0	0	0	0
Phase I 40mg: Concurrent CRT Other- not protocol specified	1	0	0	0	0
Phase I 80mg: Concurrent CRT Adverse Event	0	2	0	0	0
Phase I 120mg: Concurrent CRT Refusal unrelated to AE	0	0	1	0	0
Phase II Concurrent CRT Adverse Event	0	0	0	3	3
Phase II Concurrent CRT Refusal unrelated to AE	0	0	0	3	0
Phase II: Consolidation Therapy Adverse Event	0	0	0	2	1
Phase II: Consolidation Therapy Refusal unrelated to AE	0	0	0	2	0
Phase II: Consolidation Therapy Progression/relapse	0	0	0	1	1

Baseline Characteristics

Veliparib With or Without Radiation Therapy, Carboplatin, and Paclitaxel in Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I 40mg Veliparib Cohort n=8 Participants Participants undergo 3D-CRT and receive 40 mg veliparib, carboplatin, and paclitaxel during RT 3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Veliparib: Given PO	Phase I 80mg Veliparib Cohort n=7 Participants Participants undergo 3D-CRT and receive 80 mg veliparib, carboplatin, and paclitaxel during RT 3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Veliparib: Given PO	Phase I 120mg Veliparib Cohort n=6 Participants Participants undergo 3D-CRT and receive 120 mg veliparib, carboplatin, and paclitaxel during RT 3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Veliparib: Given PO	Arm I (RT, Veliparib, Carboplatin, Paclitaxel) n=18 Participants Patients undergo 3D-CRT and receive veliparib, carboplatin, and paclitaxel as in Phase I induction and consolidation therapy. 3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Veliparib: Given PO	Arm II (3D-CRT, Placebo, Carboplatin, Paclitaxel) n=13 Participants Patients undergo 3D-CRT as in arm I. Patients also receive placebo PO BID on days 1-43 and carboplatin and paclitaxel as in Phase I. Within 4-6 weeks after completion of chemotherapy and radiation therapy, patients receive placebo on days 1-7 and carboplatin and paclitaxel as in Phase I. 3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Placebo Administration: Given PO	Total n=52 Participants Total of all reporting groups
Age, Continuous	69.2 years n=10 Participants	66.5 years n=10 Participants	69.7 years n=20 Participants	64.7 years n=45 Participants	65.0 years n=44 Participants	67.0 years n=45 Participants
Sex: Female, Male Female	3 Participants n=10 Participants	3 Participants n=10 Participants	1 Participants n=20 Participants	11 Participants n=45 Participants	6 Participants n=44 Participants	24 Participants n=45 Participants
Sex: Female, Male Male	5 Participants n=10 Participants	4 Participants n=10 Participants	5 Participants n=20 Participants	7 Participants n=45 Participants	7 Participants n=44 Participants	28 Participants n=45 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	1 Participants n=45 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=10 Participants	7 Participants n=10 Participants	5 Participants n=20 Participants	18 Participants n=45 Participants	13 Participants n=44 Participants	51 Participants n=45 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Asian	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	2 Participants n=45 Participants	0 Participants n=44 Participants	3 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Black or African American	0 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=20 Participants	2 Participants n=45 Participants	1 Participants n=44 Participants	4 Participants n=45 Participants
Race (NIH/OMB) White	7 Participants n=10 Participants	6 Participants n=10 Participants	5 Participants n=20 Participants	13 Participants n=45 Participants	12 Participants n=44 Participants	43 Participants n=45 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants	1 Participants n=45 Participants	0 Participants n=44 Participants	2 Participants n=45 Participants
Zubrod Performance Status 0	3 Participants n=10 Participants	4 Participants n=10 Participants	4 Participants n=20 Participants	7 Participants n=45 Participants	3 Participants n=44 Participants	21 Participants n=45 Participants
Zubrod Performance Status 1	5 Participants n=10 Participants	3 Participants n=10 Participants	2 Participants n=20 Participants	11 Participants n=45 Participants	10 Participants n=44 Participants	31 Participants n=45 Participants
Stage IIIA	5 Participants n=10 Participants	5 Participants n=10 Participants	6 Participants n=20 Participants	7 Participants n=45 Participants	5 Participants n=44 Participants	28 Participants n=45 Participants
Stage IIIB	3 Participants n=10 Participants	2 Participants n=10 Participants	0 Participants n=20 Participants	11 Participants n=45 Participants	8 Participants n=44 Participants	24 Participants n=45 Participants
Histology Squamous cell	3 Participants n=10 Participants	3 Participants n=10 Participants	2 Participants n=20 Participants	10 Participants n=45 Participants	5 Participants n=44 Participants	23 Participants n=45 Participants
Histology Adenocarcinoma	5 Participants n=10 Participants	4 Participants n=10 Participants	3 Participants n=20 Participants	8 Participants n=45 Participants	8 Participants n=44 Participants	28 Participants n=45 Participants
Histology Other	0 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	1 Participants n=45 Participants
Baseline LDH Normal	4 Participants n=10 Participants	5 Participants n=10 Participants	6 Participants n=20 Participants	16 Participants n=45 Participants	9 Participants n=44 Participants	40 Participants n=45 Participants
Baseline LDH Elevated	1 Participants n=10 Participants	2 Participants n=10 Participants	0 Participants n=20 Participants	2 Participants n=45 Participants	3 Participants n=44 Participants	8 Participants n=45 Participants
Baseline LDH Not reported	3 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	1 Participants n=44 Participants	4 Participants n=45 Participants
Smoking Status Current smoker	1 Participants n=10 Participants	0 Participants n=10 Participants	3 Participants n=20 Participants	8 Participants n=45 Participants	6 Participants n=44 Participants	18 Participants n=45 Participants
Smoking Status Former status	6 Participants n=10 Participants	6 Participants n=10 Participants	1 Participants n=20 Participants	9 Participants n=45 Participants	7 Participants n=44 Participants	29 Participants n=45 Participants
Smoking Status Never smoker	1 Participants n=10 Participants	1 Participants n=10 Participants	2 Participants n=20 Participants	1 Participants n=45 Participants	0 Participants n=44 Participants	5 Participants n=45 Participants
Weight loss past 6 months <5%	3 Participants n=10 Participants	6 Participants n=10 Participants	6 Participants n=20 Participants	14 Participants n=45 Participants	8 Participants n=44 Participants	37 Participants n=45 Participants
Weight loss past 6 months 5%-10%	5 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=20 Participants	4 Participants n=45 Participants	5 Participants n=44 Participants	15 Participants n=45 Participants

PRIMARY outcome

Timeframe: 9 weeks

Population: Eligible participants evaluable for dose limiting toxicity assessment

Outcome measures

Outcome measures
Measure	Phase I 40mg Veliparib n=6 Participants During induction, participants undergo 3D-CRT and receive 40 mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks. During consolidation, participants receive 40 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase I 80mg Veliparib n=6 Participants During induction, participants undergo 3D-CRT and receive 80mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks. During consolidation, participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase I 120mg Veliparib n=5 Participants During induction, participants undergo 3D-CRT and receive 120mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks. During consolidation, participants receive 120 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) Participants receive 80mg placebo (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
Maximum Tolerated Dose of Veliparib When Given Concurrently With Standard Carboplatin/Paclitaxel and Radiotherapy, Determined According to Incidence of Dose Limiting Toxicity (DLT) (Phase I)	1 dose limiting toxicity	1 dose limiting toxicity	0 dose limiting toxicity	—

PRIMARY outcome

Timeframe: The time from randomization to progression or death due to any cause, assessed up to 5 years

Population: All eligible participants

Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause. Participants last known to be alive are censored at date of last contact. Assessed by Response Evaluation Criteria in Solid Tumors, RECIST 1.1

Outcome measures

Outcome measures
Measure	Phase I 40mg Veliparib n=18 Participants During induction, participants undergo 3D-CRT and receive 40 mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks. During consolidation, participants receive 40 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase I 80mg Veliparib n=13 Participants During induction, participants undergo 3D-CRT and receive 80mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks. During consolidation, participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase I 120mg Veliparib During induction, participants undergo 3D-CRT and receive 120mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks. During consolidation, participants receive 120 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) Participants receive 80mg placebo (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
Progression-free Survival of Patients Treated With Chemoradiotherapy Plus Veliparib (Phase II)	9.3 months Interval 7.3 to 17.4	9.9 months Interval 5.7 to 23.6	—	—

SECONDARY outcome

Timeframe: Up to 5 years

Population: All eligible participants

From date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.

Outcome measures

Outcome measures
Measure	Phase I 40mg Veliparib n=18 Participants During induction, participants undergo 3D-CRT and receive 40 mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks. During consolidation, participants receive 40 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase I 80mg Veliparib n=13 Participants During induction, participants undergo 3D-CRT and receive 80mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks. During consolidation, participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase I 120mg Veliparib During induction, participants undergo 3D-CRT and receive 120mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks. During consolidation, participants receive 120 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) Participants receive 80mg placebo (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
Overall Survival (Phase II)	27.6 months Interval 17.4 to 27.6	15.2 months Interval 6.6 to 20.6	—	—

SECONDARY outcome

Timeframe: Up to 5 years

Population: All eligible participants

ORR is defined as the percentage of participants with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1

Outcome measures

Outcome measures
Measure	Phase I 40mg Veliparib n=18 Participants During induction, participants undergo 3D-CRT and receive 40 mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks. During consolidation, participants receive 40 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase I 80mg Veliparib n=13 Participants During induction, participants undergo 3D-CRT and receive 80mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks. During consolidation, participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase I 120mg Veliparib During induction, participants undergo 3D-CRT and receive 120mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks. During consolidation, participants receive 120 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) Participants receive 80mg placebo (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
Objective Response Rate (Phase II)	56 percentage of participants Interval 31.0 to 78.0	69 percentage of participants Interval 38.0 to 91.0	—	—

SECONDARY outcome

Timeframe: Duration of treatment and follow up until death or 5 years post registration

Population: Up to 4 weeks after completion of consolidation therapy

Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Outcome measures

Outcome measures
Measure	Phase I 40mg Veliparib n=17 Participants During induction, participants undergo 3D-CRT and receive 40 mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks. During consolidation, participants receive 40 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase I 80mg Veliparib n=13 Participants During induction, participants undergo 3D-CRT and receive 80mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks. During consolidation, participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase I 120mg Veliparib n=12 Participants During induction, participants undergo 3D-CRT and receive 120mg veliparib (PO twice daily), carboplatin, and paclitaxel for 6 weeks. During consolidation, participants receive 120 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) n=10 Participants Participants receive 80mg placebo (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Anemia	1 Participants	0 Participants	1 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Anorexia	1 Participants	1 Participants	1 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Dehydration	0 Participants	1 Participants	1 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Diarrhea	0 Participants	0 Participants	1 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Dysphagia	0 Participants	0 Participants	2 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Esophageal pain	1 Participants	0 Participants	0 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Esophagitis	1 Participants	1 Participants	0 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Fatigue	1 Participants	1 Participants	1 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Hyperglycemia	1 Participants	0 Participants	0 Participants	1 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Hypocalcemia	0 Participants	1 Participants	0 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Hypoglycemia	0 Participants	1 Participants	0 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Hypokalemia	0 Participants	1 Participants	0 Participants	1 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Hypomagnesemia	0 Participants	1 Participants	0 Participants	1 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Hyponatremia	0 Participants	3 Participants	0 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Hypotension	1 Participants	0 Participants	0 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Lung infection	0 Participants	1 Participants	0 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Lymphocyte count decreased	3 Participants	4 Participants	2 Participants	2 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Mucositis oral	1 Participants	0 Participants	0 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Nausea	0 Participants	0 Participants	1 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Neutrophil count decreased	3 Participants	1 Participants	3 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Platelet count decreased	1 Participants	0 Participants	1 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Pneumonitis	0 Participants	1 Participants	0 Participants	1 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Upper gastrointestinal hemorrhage	0 Participants	0 Participants	1 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Vomiting	0 Participants	1 Participants	1 Participants	0 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) Weight loss	1 Participants	0 Participants	0 Participants	1 Participants
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) White blood cell decreased	2 Participants	2 Participants	2 Participants	0 Participants

Adverse Events

Phase I 40 mg Veliparib Cohort

Serious events: 3 serious events

Other events: 8 other events

Deaths: 7 deaths

Phase I 80 mg Veliparib Cohort

Serious events: 3 serious events

Other events: 7 other events

Deaths: 5 deaths

Phase I 120 mg Veliparib Cohort

Serious events: 2 serious events

Other events: 6 other events

Deaths: 2 deaths

Phase II Arm I (Veliparib, 3D-CRT, Carboplatin, Paclitaxel)

Serious events: 2 serious events

Other events: 17 other events

Deaths: 8 deaths

Phase II Arm II (Placebo, 3D-CRT, Carboplatin, Paclitaxel)

Serious events: 3 serious events

Other events: 13 other events

Deaths: 8 deaths

Phase I Consolidation 40mg Cohort

Serious events: 1 serious events

Other events: 4 other events

Deaths: 3 deaths

Phase I Consolidation 80mg Cohort

Serious events: 0 serious events

Other events: 4 other events

Deaths: 3 deaths

Phase I Consolidation 120mg Cohort

Serious events: 1 serious events

Other events: 5 other events

Deaths: 2 deaths

Phase II Arm I Consolidation

Serious events: 3 serious events

Other events: 12 other events

Deaths: 7 deaths

Phase II Arm II Consolidation

Serious events: 1 serious events

Other events: 9 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Phase I 40 mg Veliparib Cohort n=8 participants at risk Participants undergo 3D-CRT and receive 40 mg veliparib, carboplatin, and paclitaxel during concurrent radiotherapy	Phase I 80 mg Veliparib Cohort n=7 participants at risk Participants undergo 3D-CRT and receive 80 mg veliparib, carboplatin, and paclitaxel during concurrent radiotherapy	Phase I 120 mg Veliparib Cohort n=6 participants at risk Participants undergo 3D-CRT and receive 120 mg veliparib, carboplatin, and paclitaxel during concurrent radiotherapy	Phase II Arm I (Veliparib, 3D-CRT, Carboplatin, Paclitaxel) n=17 participants at risk Participants undergo 3D-CRT and receive 120 mg veliparib, carboplatin, and paclitaxel during concurrent radiotherapy	Phase II Arm II (Placebo, 3D-CRT, Carboplatin, Paclitaxel) n=13 participants at risk Participants undergo 3D-CRT and receive placebo, carboplatin, and paclitaxel during concurrent radiotherapy	Phase I Consolidation 40mg Cohort n=4 participants at risk Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase I Consolidation 80mg Cohort n=5 participants at risk Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase I Consolidation 120mg Cohort n=5 participants at risk Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase II Arm I Consolidation n=12 participants at risk Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase II Arm II Consolidation n=10 participants at risk Participants receive 80 mg placebo (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
Blood and lymphatic system disorders Anemia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Cardiac disorders Atrial fibrillation	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Cardiac disorders Atrial flutter	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Cardiac disorders Sinus bradycardia	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Cardiac disorders Supraventricular tachycardia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Cardiac disorders Ventricular tachycardia	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Dysphagia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Esophageal perforation	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Esophagitis	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
General disorders Death NOS	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
General disorders Infusion related reaction	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
General disorders Non-cardiac chest pain	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Infections and infestations Lung infection	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Infections and infestations Sepsis	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Lymphocyte count decreased	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Neutrophil count decreased	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Weight loss	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations White blood cell decreased	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Anorexia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Hypokalemia	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Nervous system disorders Intracranial hemorrhage	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Nervous system disorders Presyncope	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Nervous system disorders Syncope	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Nervous system disorders Vasovagal reaction	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Vascular disorders Hypotension	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Vascular disorders Thromboembolic event	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.

Other adverse events

Other adverse events
Measure	Phase I 40 mg Veliparib Cohort n=8 participants at risk Participants undergo 3D-CRT and receive 40 mg veliparib, carboplatin, and paclitaxel during concurrent radiotherapy	Phase I 80 mg Veliparib Cohort n=7 participants at risk Participants undergo 3D-CRT and receive 80 mg veliparib, carboplatin, and paclitaxel during concurrent radiotherapy	Phase I 120 mg Veliparib Cohort n=6 participants at risk Participants undergo 3D-CRT and receive 120 mg veliparib, carboplatin, and paclitaxel during concurrent radiotherapy	Phase II Arm I (Veliparib, 3D-CRT, Carboplatin, Paclitaxel) n=17 participants at risk Participants undergo 3D-CRT and receive 120 mg veliparib, carboplatin, and paclitaxel during concurrent radiotherapy	Phase II Arm II (Placebo, 3D-CRT, Carboplatin, Paclitaxel) n=13 participants at risk Participants undergo 3D-CRT and receive placebo, carboplatin, and paclitaxel during concurrent radiotherapy	Phase I Consolidation 40mg Cohort n=4 participants at risk Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase I Consolidation 80mg Cohort n=5 participants at risk Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase I Consolidation 120mg Cohort n=5 participants at risk Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase II Arm I Consolidation n=12 participants at risk Participants receive 80 mg veliparib (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.	Phase II Arm II Consolidation n=10 participants at risk Participants receive 80 mg placebo (PO twice daily, Days 1-7, Days 22-28), carboplatin, and paclitaxel for 2 cycles.
Blood and lymphatic system disorders Anemia	75.0% 6/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	42.9% 3/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	50.0% 3/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	47.1% 8/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	76.9% 10/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	75.0% 3/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	40.0% 2/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	41.7% 5/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	90.0% 9/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Cardiac disorders Atrial fibrillation	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Cardiac disorders Atrial flutter	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Cardiac disorders Cardiac disorders-Other	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Cardiac disorders Chest pain - cardiac	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Cardiac disorders Mobitz (type) II atrioventricular block	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Cardiac disorders Palpitations	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Cardiac disorders Paroxysmal atrial tachycardia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Cardiac disorders Sinus bradycardia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Cardiac disorders Sinus tachycardia	25.0% 2/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	23.1% 3/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 2/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Cardiac disorders Supraventricular tachycardia	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Ear and labyrinth disorders Ear pain	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Ear and labyrinth disorders Tinnitus	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Eye disorders Blurred vision	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Eye disorders Conjunctivitis	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Eye disorders Eye disorders-Other	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.0% 3/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Eye disorders Photophobia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Abdominal pain	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	11.8% 2/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Constipation	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	28.6% 2/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	50.0% 3/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	35.3% 6/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.8% 4/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 2/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 2/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Diarrhea	25.0% 2/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	28.6% 2/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	33.3% 2/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	35.3% 6/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 2/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.0% 3/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Dry mouth	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Dyspepsia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	42.9% 3/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	23.1% 3/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	40.0% 2/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Dysphagia	25.0% 2/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	28.6% 2/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	50.0% 3/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	35.3% 6/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	38.5% 5/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	33.3% 4/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.0% 3/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Esophageal pain	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Esophagitis	62.5% 5/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	57.1% 4/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	66.7% 4/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	47.1% 8/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	61.5% 8/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	75.0% 3/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	40.0% 2/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.0% 3/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Gastrointestinal disorders-Other	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	28.6% 2/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Hemorrhoids	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Mucositis oral	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Nausea	50.0% 4/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	42.9% 3/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	50.0% 3/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	47.1% 8/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	61.5% 8/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	50.0% 2/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 2/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	50.0% 5/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Stomach pain	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Gastrointestinal disorders Vomiting	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	33.3% 2/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	29.4% 5/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.8% 4/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 2/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
General disorders Chills	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
General disorders Edema limbs	25.0% 2/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 2/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 2/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
General disorders Fatigue	50.0% 4/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	57.1% 4/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	83.3% 5/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	82.4% 14/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	61.5% 8/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	50.0% 2/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	60.0% 3/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	66.7% 8/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	80.0% 8/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
General disorders Fever	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	17.6% 3/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 2/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
General disorders General disorders and admin site conditions - Other	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
General disorders Injection site reaction	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
General disorders Malaise	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
General disorders Non-cardiac chest pain	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	42.9% 3/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
General disorders Pain	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	11.8% 2/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Immune system disorders Allergic reaction	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Infections and infestations Bronchial infection	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Infections and infestations Esophageal infection	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Infections and infestations Lung infection	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Infections and infestations Mucosal infection	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Infections and infestations Papulopustular rash	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Infections and infestations Skin infection	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Infections and infestations Upper respiratory infection	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Infections and infestations Urinary tract infection	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Injury, poisoning and procedural complications Dermatitis radiation	37.5% 3/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	57.1% 4/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	33.3% 2/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	17.6% 3/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	23.1% 3/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Injury, poisoning and procedural complications Fracture	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Alanine aminotransferase increased	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Alkaline phosphatase increased	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	23.1% 3/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.0% 3/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Aspartate aminotransferase increased	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Blood bilirubin increased	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations CD4 lymphocytes decreased	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Cardiac troponin I increased	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Cholesterol high	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Creatinine increased	25.0% 2/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Ejection fraction decreased	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations INR increased	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Investigations-Other	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Lymphocyte count decreased	75.0% 6/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	71.4% 5/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	66.7% 4/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	41.2% 7/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	69.2% 9/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	50.0% 2/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	40.0% 2/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	40.0% 2/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 2/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	60.0% 6/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Neutrophil count decreased	37.5% 3/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	57.1% 4/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	50.0% 3/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	35.3% 6/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	80.0% 4/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	33.3% 4/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Platelet count decreased	37.5% 3/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	66.7% 4/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	29.4% 5/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.8% 4/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	40.0% 2/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	41.7% 5/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 2/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Weight gain	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations Weight loss	37.5% 3/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	29.4% 5/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	23.1% 3/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 3/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.0% 3/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Investigations White blood cell decreased	75.0% 6/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	71.4% 5/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	50.0% 3/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	35.3% 6/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	61.5% 8/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	60.0% 3/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 3/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 2/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Anorexia	25.0% 2/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	28.6% 2/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	29.4% 5/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.8% 4/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 3/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 2/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Dehydration	25.0% 2/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	11.8% 2/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	23.1% 3/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Hypercalcemia	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	28.6% 2/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	33.3% 2/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	17.6% 3/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	38.5% 5/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.0% 3/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	33.3% 2/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Hypermagnesemia	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Hypoalbuminemia	37.5% 3/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	17.6% 3/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	53.8% 7/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 2/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	40.0% 4/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Hypocalcemia	25.0% 2/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	23.1% 3/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Hypokalemia	37.5% 3/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	23.1% 3/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 2/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Hypomagnesemia	25.0% 2/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.8% 4/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	40.0% 4/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Hyponatremia	50.0% 4/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	33.3% 2/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	17.6% 3/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	61.5% 8/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	23.1% 3/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	40.0% 2/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 2/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Musculoskeletal and connective tissue disorders Back pain	25.0% 2/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	11.8% 2/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.0% 3/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Musculoskeletal and connective tissue disorders Bone pain	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	50.0% 2/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	23.1% 3/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 2/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Musculoskeletal and connective tissue disorders Myalgia	37.5% 3/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	50.0% 2/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.0% 3/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Nervous system disorders Dizziness	25.0% 2/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	23.5% 4/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.8% 4/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	50.0% 2/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 2/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 2/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Nervous system disorders Dysgeusia	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	57.1% 4/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	40.0% 2/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Nervous system disorders Headache	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	46.2% 6/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.0% 3/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Nervous system disorders Hypersomnia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Nervous system disorders Neuralgia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Nervous system disorders Paresthesia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 2/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Nervous system disorders Peripheral sensory neuropathy	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	11.8% 2/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	23.1% 3/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	40.0% 2/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 3/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 2/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Nervous system disorders Presyncope	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Nervous system disorders Seizure	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Nervous system disorders Somnolence	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Nervous system disorders Tremor	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Psychiatric disorders Agitation	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Psychiatric disorders Anxiety	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	33.3% 2/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	11.8% 2/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Psychiatric disorders Confusion	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Psychiatric disorders Depression	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Psychiatric disorders Insomnia	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 2/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Renal and urinary disorders Proteinuria	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Renal and urinary disorders Urinary frequency	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Renal and urinary disorders Urinary incontinence	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Renal and urinary disorders Urinary tract pain	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 2/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	28.6% 2/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	50.0% 3/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	35.3% 6/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 2/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	50.0% 5/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Dyspnea	62.5% 5/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	17.6% 3/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	30.8% 4/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 2/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 2/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	33.3% 2/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	28.6% 2/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Hypoxia	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Nasal congestion	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Productive cough	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	42.9% 3/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	33.3% 2/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	17.6% 3/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	23.1% 3/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 2/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Resp, thoracic and mediastinal disorders - Other	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Sleep apnea	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Sore throat	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	8.3% 1/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Respiratory, thoracic and mediastinal disorders Wheezing	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	11.8% 2/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	23.5% 4/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	50.0% 2/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	40.0% 2/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	41.7% 5/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	60.0% 6/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Skin and subcutaneous tissue disorders Dry skin	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Skin and subcutaneous tissue disorders Pruritus	37.5% 3/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Skin and subcutaneous tissue disorders Rash acneiform	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Skin and subcutaneous tissue disorders Rash maculo-papular	37.5% 3/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	28.6% 2/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	11.8% 2/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Vascular disorders Flushing	0.00% 0/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	15.4% 2/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Vascular disorders Hypertension	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	28.6% 2/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 1/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	23.1% 3/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 1/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	20.0% 2/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Vascular disorders Hypotension	37.5% 3/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	14.3% 1/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	5.9% 1/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	25.0% 1/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	16.7% 2/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.
Vascular disorders Thromboembolic event	12.5% 1/8 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/7 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/6 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/17 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	7.7% 1/13 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/4 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/5 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	0.00% 0/12 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.	10.0% 1/10 • Duration of treatment and follow up until death or 5 years post registration Adverse Events (AEs) are reported by CTCAE Version 4.0. 21 participants in phase I and 31 participants in phase II who were eligible and received protocol therapy were assessed for AEs. 1 participant in phase II arm 1 did not receive protocol therapy so was not assessed for AEs. All cause modality analysis will include all eligible participants as participants at risk.

Additional Information

Lung Committee Statistician

SWOG Statistics and Data Management Center

Phone: 2066674623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60