Table 2

Adverse events

Preferred term	Grade (CTCAE)	Part I (n=16)	Part II (n=12)	Part III (n=14)
Preferred term	Grade (CTCAE)	No. of patients (%)	No. of patients (%)	No. of patients (%)
Fever/influenza like illness	Grade 1–2	12 (75)	8 (67)	12 (85)
Fever/influenza like illness	Grade 3–4	1 (6.3)	0	0
Asthenia	Grade 1–2	2 (12.5)	5 (42.0)	3 (21)
Asthenia	Grade 3–4	0	1 (8.3)	0
Thrombocytopenia/platelet count decreased	Grade 1–2	1 (6.3)	3 (25)	2 (14)
Thrombocytopenia/platelet count decreased	Grade 3–4	1 (6.3)	4 (33)*	0
Nausea	Grade 1–2	2 (12.5)	3 (25.0)	3 (21.4)
Vomiting	Grade 1–2	3 (18.8)	2 (16.7)	3 (21.4)
Musculoskeletal pain	Grade 1–2	3 (19)	4 (33)	0
Decreased appetite	Grade 1–2	3 (19)	3 (25.0)	0
Alanine aminotransferase increased	Grade 1–2	1 (6.3)	0	2 (14.3)
Alanine aminotransferase increased	Grade 3–4	1 (6.3)	0	1 (7.1)
Diarrhea	Grade 1–2	3 (18.8)	1 (8.3)	0
Diarrhea	Grade 3–4	0	0	1 (7.1)
Aspartate transaminase increased	Grade 1–2	1 (6.3)	0	0
Aspartate transaminase increased	Grade 3–4	2 (12,5)	0	1 (7.1)
Neutropenia/neutrophil count decreased	Grade 1–2	2 (12.5)	1 (8.3)	0
Neutropenia/neutrophil count decreased	Grade 3–4	0	1 (8.3)	0
Headache	Grade 1–2	1 (6.3)	1 (8.3)	1 (7.1)
Hypotension	Grade 1–2	2 (12.5)	1 (8.3)	0
Febrile neutropenia	Grade 3–4	0	2 (16.7)	0
Hepatic enzymes increased	Grade 1–2	0	1 (8.3)	0
Hepatic enzymes increased	Grade 3–4	0	1 (8.3)	0
Lipase increased	Grade 3–4	2 (12.5)	0	0
Amylase increased	Grade 1–2	1 (6.3)	0	0
Amylase increased	Grade 3–4	1 (6.3)	0	0
Dizziness	Grade 1–2	1 (6.3)	1 (8.3)	0
Arthralgia	Grade 1–2	2 (12.5)	0	0
Dyspnea	Grade 1–2	2 (12.5)	0	0
Enterocolitis	Grade 5	0	1 (8.3)*	0

VCN-01 related adverse events (PT) that occurred in more than one patient.
Coding was done with MedDRA Dictionary V.20.0. Worst case of severity is selected within a same patient.
*One patient enrolled in Part II developed concurrent grade 4 thrombocytopenia and grade 5 enterocolitis.
CTCAE, Common Terminology Criteria for Adverse Events.