Table 3.

Adverse events considered at least possibly related to study treatment, all grades, by number of patients experiencing the event.

	Grade
Adverse Event	0	1	2	3	4	Total
Leukopenia	18	10	8	3	3	42
Thrombocytopenia	9	22	5	4	2	42
Neutropenia	27	2	6	2	5	42
Anemia	0	7	25	10	0	42
Other hematologic	33	4	3	2	0	42
Coagulation	40	1	0	1	0	42
Hemorrhage	38	2	2	0	0	42
Allergic reaction	33	5	3	1	0	42
Dermatologic	11	3	27	1	0	42
Auditory	40	0	2	0	0	42
Fatigue	11	15	9	7	0	42
Gastrointestinal	12	12	12	5	1	42
Genitourinary/Renal	36	3	3	0	0	42
Hepatic	35	7	0	0	0	42
Infection	30	3	8	1	0	42
Metabolic1	21	5	9	7	0	42
Lymphocytes	33	5	4	0	0	42
Musculoskeletal	38	3	0	1	0	42
Neurotoxicity	32	7	2	1	0	42
Peripheral neuropathy	33	7	2	0	0	42
Ocular2	35	4	3	0	0	42
Pain	23	12	5	1	1	42
Pulmonary3	32	6	3	0	1	42
Cardiovascular4	37	4	0	1	0	42
Constitutional5	28	4	10	0	0	42
Endocrine	40	1	1	0	0	42
Hospitalization	40	2	0	0	0	42

The median white blood count for those 24 patients experiencing leukopenia was 2950 (range: 700−3700). The median platelet nadir for those 33 patients experiencing thrombocytopenia was 87,000 (range: 11,000−131,000).

¹metabolic toxicities included: hyponatremia, hypokalemia, hyperglycemia, hypoalbuminemia, and elevations in AST or ALT.

²Ocular toxicities included tearing (epiphora), periorbital edema, photophobia, and blurred vision.

³The grade 4 event occurred after cycle 12 and was possibly related to study treatment.

⁴Cardiovascular toxicity, grade 3, was a deep venous thrombosis

⁵Constitutional symptoms, other than fatigue, included weight loss, and fever without infection, at least possibly related to study treatment.