Table 3. Serious Adverse Events.

Adverse Event	All(% (n/total))	Placebo (% (n/total))	LD (% (n/total))	HD (% (n/total))	JT p-value	Pooled Rx Fisher's p-value
Dyspnea (shortness of breath)	15 (10/66)	19 (4/21)	17 (4/23)	9 (2/22)	0.3665	0.7139
PEG Placement (outpatient)	14 (9/66)	29 (6/21)	9 (2/23)	5 (1/22)	0.0256	0.0242
Cholelithiasis	11 (7/66)	0 (0/21)	13 (3/23)	18 (4/22)	0.0827	0.0874
Line infection	8 (5/66)	10 (2/21)	13 (3/23)	0 (0/22)	0.1942	0.6499
Thrombosis/thrombus/embolism	3 (2/66)	5 (1/21)	0 (0/23)	5 (1/22)	1.0000	0.5385
Pnuemonia	4 (2/66)	0 (0/21)	8 (2/23)	0 (0/22)	0.7846	1.0000
CNS cerebrovascular ischemia	2 (1/66)	0 (0/21)	4 (1/23)	0 (0/22)	1.0000	1.0000
Clostridium difficile colitis	2 (1/66)	0 (0/21)	4 (1/23)	0 (0/22)	1.0000	1.0000
Constipation	2 (1/66)	5 (1/21)	0 (0/23)	0 (0/22)	0.3182	0.3182
Sudden Death	2 (1/66)	0 (0/21)	0 (0/23)	5 (1/22)	0.6515	1.0000
Fever (in the absence of neutropenia)	2 (1/66)	5 (1/21)	0 (0/23)	0 (0/22)	0.3182	0.3182
Subarachnoid hemorrhage	2 (1/66)	0 (0/21)	4 (1/23)	0 (0/22)	1.0000	1.0000
Abdomen Pain NOS	2 (1/66)	5 (1/21)	0 (0/23)	0 (0/22)	0.3182	0.3182
Pancreatitis	2 (1/66)	0 (0/21)	0 (0/23)	5 (1/22)	0.6515	1.0000
Pulmonary edema:	2 (1/66)	0 (0/21)	0 (0/23)	5 (1/22)	0.6515	1.0000
Hysterectomy:	2 (1/66)	5 (1/21)	0 (0/23)	0 (0/22)	0.3182	0.3182
Thrombosis/embolism (vascular access-related)	2 (1/66)	5 (1/21)	0 (0/23)	0 (0/22)	0.3182	0.3182