Table 3.

Number of Patients with Treatment-Related Adverse Events by Category and Grade

	Any time (n=44) Grade					Acute (n=44) Grade					Late (n=44) Grade
Category	1	2	3	4	5	1	2	3	4	5	1	2	3	4	5
Allergy/immunology	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0
Auditory/ear	0	19	6	1a	0	0	16	4	1	0	0	12	3	0	0
Blood/bone marrow	1	7	7	9b	0	1	7	7	9	0	2	2	0	0	0
Cardiac arrhythmia	0	2	0	0	0	0	2	0	0	0	0	0	0	0	0
Cardiac general	2	0	3	0	0	2	0	3	0	0	0	0	0	0	0
Coagulation	1	1	0	0	0	1	1	0	0	0	0	0	0	0	0
Constitutional symptoms	4	18	17	0	0	4	19	16	0	0	10	9	2	0	0
Dermatology/skin	11	20	9	0	0	12	18	9	0	0	16	5	0	0	0
Endocrine	0	4	1	0	0	1	1	1	0	0	0	3	0	0	0
Gastrointestinal	0	5	38	1c	0	0	5	38	1	0	9	21	7	0	0
Hemorrhage/bleeding	8	1	0	0	0	5	1	0	0	0	3	0	0	0	0
Infection	0	8	7	1d	0	0	8	7	1	0	0	0	1	0	0
Lymphatics	4	4	1	0	0	3	2	1	0	0	3	2	0	0	0
Metabolic/laboratory	4	6	12	0	0	4	6	12	0	0	3	2	0	0	0
Musculoskeletal/soft tissue	5	10	4	0	0	4	7	4	0	0	9	6	1	0	0
Neurology	20	8	2	0	0	14	7	1	0	0	16	4	1	0	0
Pain	4	15	17	2e	0	4	15	16	2	0	5	8	2	0	0
Pulmonary/upper respiratory	10	7	6	0	0	9	7	6	0	0	7	0	0	0	0
Sexual/reproductive function	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Syndromes	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Vascular	0	1	0	1f	0	0	1	0	1	0	0	0	0	0	0

Includes adverse events where relationship to protocol treatment is missing.

Adverse events were graded with CTCAE version 3.0.

The late period is defined as > 90 days after the end of treatment.

^atinnitus –1.

^bleukopenia NOS – 6; lymphopenia – 5; neutrophil count – 5; hemoglobin – 1.

^cradiation mucositis – 1.

^dinfection with grade 3–4 neutrophils (blood) – 1; infection with grade 3–4 neutrophils [skin (cellulitis)] – 1.

^epharyngolaryngeal pain – 2.

^fthrombosis – 1.