Table 3. Summary of Reported Adverse Events (AEs) by Grade.

	Chemotherapy plus rmhTNF (n = 261)			Chemotherapy (n = 259)
	All Grade No. (%)	Grade 3 No. (%)	Grade 4 No. (%)	All Grade No. (%)	Grade 3 No. (%)	Grade 4 No. (%)
AEs Experienced by >10% of Patients
Diarrhea	256 (97)	1 (<1)	0	259 (98)	3 (1.1)	0
Rash	256 (97)	1 (<1)	2 (<1)	264 (100)	1 (<1)	0
Albuminuria	255 (96)	1 (<1)	0	262 (99)	2 (<1)	0
Arrhythmia	254 (96)	0	0	262 (99)	0	0
Infection (Non-neutropenia)	246 (93)	2 (<1)	0	262 (99)	1 (<1)	0
ALT Increase	246 (93)	5 (2)	0	248 (94)	8 (3)	0
AST Increase	234 (89)	3 (1)	1 (<1)	247 (94)	2 (<1)	1 (<1)
Stomatitis	246 (93)	0	0	264 (100)	1 (<1)	0
Thrombocytopenia	207 (78)	8 (3)	5 (2)	182 (69)	13 (5)	11 (4)
Fatigue	185 (70)	5 (2)	0	169 (64)	4 (1)	0
Myalgia	185 (70)	1 (<1)	0	259 (98)	0	0
Flu-like symptoms	170 (64)	10 (4)	1 (<1)	264 (100)	0	0
Pyrexia	162 (61)	16 (6)	8 (3)	248 (94)	0	0
Neutropenia	133 (50)	34 (13)	8 (3)	121 (46)	21 (8)	16 (6)
Leukopenia	122 (46)	29 (11)	13 (5)	66 (25)	24 (9)	13 (5)
Nausea	117 (44)	8 (3)	0	63 (24)	24 (9)	3 (1)
Vomiting	115 (43)	5 (2)	0	58 (22)	15 (6)	0
Abdominal Pain	87 (33)	0	0	74 (28)	0	0
Chest Pain	85 (32)	0	0	58 (22)	0	0
AEs of Special Interest
Myalgia	185 (70)	1 (<1)	0	259 (98)	0	0
Flu-like symptoms*	170 (64)	10 (4)	1 (<1)	264 (100)	0	0
Pyrexia*	162 (61)	16 (6)	8 (3)	248 (94)	0	0
Febrile Neutropenia	16 (6)	0	0	21 (8)	0	0
Hematemesis *	16 (6)	0	3 (1)	0	0	0
Hypotension	2 (<1)	2 (<1)	0	0	0	0
Pulmonary Embolus	1 (<1)	1 (<1)	0	1 (<1)	1 (<1)	0
Cardiac event	1 (<1)	1 (<1)	0	2 (<1)	2 (<1)	0

ALT: Alanine Transaminase, AST: Aspartate Aminotransferase, *p<0.05 Comparison of Grade 3 and 4.