Table 3.

Drug-Related Toxicities and Serious Adverse Events

	Standard Treatment Cohort (n=25)						Alternate Treatment Schedule Cohort (n=6*)§
	Grades 1–2†		Grade 3‡		Grade 4‡		Grades 1–2†		Grade 3‡		Grade 4‡
	n	%	n	%	n	%	n	%	n	%	n	%
Allergy/immunology
Allergic Reaction	3	12.0%	2	8.0%	1	4.0%	0	0.0%	0	0.0%	0	0.0%
Blood/Bone Marrow
Anemia	8	32.0%	3	12.0%	0	0.0%	1	16.7%	1	16.7%	0	0.0%
Leukocytes	5	20.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%
Cardiac
Sinus Arrhythmia	0	0.0%	0	0.0%	0	0.0%	0	0.0%	1	16.7%	0	0.0%
Cardiac Arrhythmia	0	0.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%	1	16.7%
Prolonged QTc Interval	0	0.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%	1	16.7%
Pericardial effusion	2	8.0%	0	0.0%	1	4.0%	0	0.0%	0	0.0%	0	0.0%
Constitutional
Fatigue	18	72.0%	2	8.0%	0	0.0%	4	66.7%	0	0.0%	0	0.0%
Weight Loss	9	36.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%
Fever	5	20.0%	0	0.0%	0	0.0%	1	16.7%	0	0.0%	0	0.0%
Rigors	4	16.0%	0	0.0%	0	0.0%	1	16.7%	0	0.0%	0	0.0%
Dermatology/Skin
Rash	13	52.0%	0	0.0%	0	0.0%	3	50.0%	0	0.0%	0	0.0%
Dry skin	7	28.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%
Pruritis	3	12.0%	0	0.0%	0	0.0%	1	16.7%	0	0.0%	0	0.0%
Wound complication	0	0.0%	1	4.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%
Gastrointestinal
Anorexia	15	60.0%	0	0.0%	0	0.0%	4	66.7%	0	0.0%	0	0.0%
Nausea	14	56.0%	3	12.0%	0	0.0%	5	83.3%	0	0.0%	0	0.0%
Vomiting	9	36.0%	3	12.0%	0	0.0%	2	33.3%	0	0.0%	0	0.0%
Diarrhea	8	32.0%	0	0.0%	0	0.0%	1	16.7%	0	0.0%	0	0.0%
Constipation	6	24.0%	1	4.0%	0	0.0%	2	33.3%	0	0.0%	0	0.0%
Gerd	4	16.0%	0	0.0%	0	0.0%	1	16.7%	2	33.3%	0	0.0%
Small Bowl Obstruction	0	0.0%	2	8.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%
Infection
Infection	2	8.0%	2	8.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%
Lymphatics
Edema	4	16.0%	0	0.0%	0	0.0%	1	16.7%	0	0.0%	0	0.0%
Metabolic
Hypophosphatemia	2	8.0%	1	4.0%	0	0.0%	2	33.3%	0	0.0%	0	0.0%
Hyponatremia	1	4.0%	1	4.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%
Hypokalemia	1	4.0%	1	4.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%
Hyperglycemia	0	0.0%	1	4.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%
Musculoskeletal
Weakness	6	24.0%	0	0.0%	0	0.0%	1	16.7%	0	0.0%	0	0.0%
Neurology
Anxiety	4	16.0%	0	0.0%	0	0.0%	1	16.7%	0	0.0%	0	0.0%
Neuropathy	3	12.0%	0	0.0%	0	0.0%	2	33.3%	0	0.0%	0	0.0%
Pain
Headache	18||	72.0%	3||	12.0%	0	0.0%	4¶	66.7%	0	0.0%	0	0.0%
Pain	8	32.0%	1	4.0%	0	0.0%	2	33.3%	2	33.3%	0	0.0%
Pulmonary/Upper Respiratory
Cough	11	44.0%	0	0.0%	0	0.0%	2	33.3%	0	0.0%	0	0.0%
Dyspnea	6	24.0%	4	16.0%	0	0.0%	1	16.7%	0	0.0%	0	0.0%
Pleural effusion**	4	16.0%	1	4.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%
Hypoxia	1	4.0%	1	4.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%
Respiratory failure	0	0.0%	0	0.0%	1	4.0%	0	0.0%	0	0.0%	0	0.0%
Renal/Genitourinary
Renal Failure	1	4.0%	1	4.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%
Vascular
Vessel injury-artery	0	0.0%	1	4.0%	0	0.0%	0	0.0%	0	0.0%	0	0.0%

^*5 of 6 patients were evaluable. One patient developed confusion after the loading dose of cetuximab and CT of brain showed metastasis and was removed from study

^†Grade 1–2 toxicities present in at least 10% of patients

^‡All Grade 3 or Grade 4 toxicities

^§1 sudden death on cycle 1, day 21; no autopsy was performed

^||Headache started the day of cetuximab loading dose and lasted 1–3 days (median 2 days) usually without other associated symptoms

^¶Headache resolved prior to starting dasatinib on day 4

^**Pleural effusion developed after 2–5 months of treatment