1

Demographics and Baseline Characteristics safety population

2

Ae listing of treatment emergent adverse event

3

Subject Disposition

4

Vital Signs Safety Population

5

Exposure to Study Medication Safety Population

1

Demographic: Subject Demographics and Baseline Characteristics Safety Population

2

Adverse event

3

Summary of Overall Treatment Emergent Adverse Event (TEAE) Information Safety Population

4

Summary of Treatment Emergent Adverse Events (TEAE) by System Organ Class and Preferred Term Safety Population

5

Concomitant medication: Concomitant Treatment Phase Medications Safety Population

6

Exposure: Exposure to Study Medication Safety Population

7

Laboratory: Laboratory shift table

8

Vitals: Summary of Change from Baseline in Vital Signs Safety Population

9

Disposition: Subject Disposition.

1

Summary of Treatment-Emergent Adverse Events by Maximum CTCAE Grade

2

Summary of vitals sign safety population

3

Coagulation values by (mean of +/- ) values by visit

4

Kaplan-meier plot of time to first abnormal laboratory test values

5

% change in tumor size from baseline.