TABLE 3.

Serious Adverse Events (SAEs) Within 90 Days of Treatment. The first column organizes CTCAE v4.0 adverse events by system and then further divides into specific adverse events. The first row indicates the grade as well as the attribution. No grade 4 events were recorded, and are thus not tabulated. Protocol-specific SAEs (SAEs that were possibly, probably, or definitely relative to study treatment) are bolded. CTCAE v4.0 = Common Terminology Criteria for Adverse Events version 4.0.

CTCAE v4.0 System/Toxicity	Grade 3				Grade 5
	Unrelated	Unlikely	Possible	Probable	Unlikely
Cardiac disorders
Heart Failure			1
Pericarditis				1
Gastrointestinal disorders
Diarrhea	1
Nausea	1
General disorders and administration site conditions
Other - Accident					1
Immune system disorders
Allergic Reaction	1
Investigations
Alanine Aminotransferase increased		1
Aspartate Aminotransferase increased		1
Respiratory, thoracic and mediastinal disorders
Other – Influenza	1
Vascular disorders
Flushing		1